ASSURE: Sunitinib Malate or Sorafenib Tosylate in Treating Patients With Kidney Cancer That Was Removed By Surgery

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Completed
CT.gov ID
NCT00326898
Collaborator
Cancer and Leukemia Group B (Other), NCIC Clinical Trials Group (Other), Southwest Oncology Group (Other)
1,943
987
3
184.3
2
0

Study Details

Study Description

Brief Summary

This randomized phase III trial studies sunitinib malate to see how well it works compared to sorafenib tosylate or placebo in treating patients with kidney cancer that has been removed by surgery. Sunitinib malate and sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib malate or sorafenib tosylate after surgery may kill any tumor cells that remain after surgery. It is not yet known whether sunitinib malate is more effective than sorafenib tosylate or placebo in treating kidney cancer.

Condition or Disease Intervention/Treatment Phase
  • Other: Laboratory Biomarker Analysis
  • Other: Placebo
  • Other: Quality-of-Life Assessment
  • Drug: Sorafenib Tosylate
  • Drug: Sunitinib Malate
Phase 3

Detailed Description

PRIMARY OBJECTIVES:
  1. To demonstrate an improvement in disease-free survival in locally advanced renal cell carcinoma patients randomly assigned to adjuvant sunitinib (sunitinib malate) (Arm A) or sorafenib (sorafenib tosylate) (Arm B) versus placebo (Arm C) after radical or partial nephrectomy.
SECONDARY OBJECTIVES:
  1. To compare overall survival of patients randomized to each of the two regimens with placebo.

  2. To further define the toxicity of prolonged administration of sunitinib or sorafenib in this patient population.

  3. To prospectively collect tumor and biological specimens to assess their characteristics and associations: novel approaches to assess angiogenesis markers in tissue, blood and urine as predictors of disease-free survival and of therapeutic benefit.

  4. To prospectively collect tumor and biological specimens to assess their characteristics and associations: the frequency of oncogene and tumor suppressor gene mutations as predictors of disease-free survival and therapeutic benefit.

  5. To prospectively collect tumor and biological specimens to assess their characteristics and associations: tumor and genetic polymorphisms as predictors of disease-free survival and therapeutic benefit.

  6. To prospectively collect tumor and biological specimens to assess their characteristics and associations: deoxyribonucleic acid (DNA) methylation profiles as predictors of outcome and of therapeutic benefit.

  7. To prospectively collect tumor and biological specimens to assess their characteristics and associations: The relationship of polymorphisms in drug metabolizing enzymes with steady state concentrations of sorafenib and sunitinib in selected patients.

  8. To study the effect of vascular endothelial growth factor (VEGF) targeted therapy on circulating endothelial cells and circulating endothelial progenitors.

  9. To prospectively assess patient-reported fatigue in order to compare the magnitude and trajectory of fatigue among renal cell carcinoma (RCC) patients randomized to adjuvant sunitinib (Arm A) or sorafenib (Arm B) to placebo (Arm C). (Quality of life objectives) X. To evaluate the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue-Short Form (SF)1, a newly developed state-of-the-science PROMIS measure for fatigue and to calibrate the PROMIS Fatigue-SF1 with the established, validated FACIT-Fatigue scale. (Quality of life objectives)

OUTLINE: Patients are randomized to 1 of 3 treatment arms.

ARM A: Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate orally (PO) once daily (QD) for 4 weeks and placebo sorafenib tosylate PO QD or twice daily (BID) for 6 weeks.

ARM B: Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate PO QD or BID for 6 weeks and placebo sunitinib malate PO QD for 4 weeks followed.

ARM C: Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate as in Arm A and placebo sunitinib malate as in Arm B.

In all arms, treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then every 12 months for 5 years.

Study Design

Study Type:
Interventional
Actual Enrollment :
1943 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
ASSURE: Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Carcinoma
Actual Study Start Date :
Apr 24, 2006
Actual Primary Completion Date :
Aug 27, 2015
Actual Study Completion Date :
Sep 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm A (sunitinib malate, placebo)

Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate PO QD for 4 weeks and placebo sorafenib tosylate PO QD or BID for 6 weeks.

Other: Laboratory Biomarker Analysis
Correlative studies

Other: Placebo
Given PO
Other Names:
  • placebo therapy
  • PLCB
  • sham therapy
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment
  • Drug: Sunitinib Malate
    Given PO
    Other Names:
  • SU011248
  • SU11248
  • sunitinib
  • Sutent
  • Experimental: Arm B (sorafenib tosylate, placebo)

    Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate PO QD or BID for 6 weeks and placebo sunitinib malate PO QD for 4 weeks followed.

    Other: Laboratory Biomarker Analysis
    Correlative studies

    Other: Placebo
    Given PO
    Other Names:
  • placebo therapy
  • PLCB
  • sham therapy
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment
  • Drug: Sorafenib Tosylate
    Given PO
    Other Names:
  • BAY 43-9006 Tosylate
  • BAY 54-9085
  • Nexavar
  • sorafenib
  • Placebo Comparator: Arm C (placebo)

    Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate as in Arm A and placebo sunitinib malate as in Arm B.

    Other: Laboratory Biomarker Analysis
    Correlative studies

    Other: Placebo
    Given PO
    Other Names:
  • placebo therapy
  • PLCB
  • sham therapy
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment
  • Outcome Measures

    Primary Outcome Measures

    1. Disease-free Survival (DFS) [Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry]

      Disease-free survival (DFS) is defined as time from randomization to recurrence, development of second primary cancer (except localized breast or prostate cancer or nonmelanoma skin cancer), or death from any cause. Patients who were alive without recurrence or qualifying second primary cancer were censored at the date of last disease evaluation.

    Secondary Outcome Measures

    1. 5-year Overall Survival Rate [Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry]

      Overall survival is defined as the time from randomization to death from any cause. Patients without a date of death were censored at the date of last contact. Kaplan-Meier method was used to estimate 5-year survival rate.

    2. Proportion of Patients With Cardiac Events [Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry]

      Cardiac event is defined as left ventricular ejection fraction (LVEF) below the institutional lower limit of normal, where the decrease was >15% absolute percentage points from baseline within 6 months.

    3. 5-year Disease-free Survival (DFS) Rate Among Patients With Clear Cell Histology [Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry]

      Disease-free survival (DFS) is defined as time from randomization to recurrence, development of second primary cancer (except localized breast or prostate cancer or nonmelanoma skin cancer), or death from any cause. Patients who were alive without recurrence or qualifying second primary cancer were censored at the date of last disease evaluation. 5-year DFS rate is the proportion of patients who are alive and disease-free at 5 years based on the Kaplan-Meier estimate.

    Other Outcome Measures

    1. The Association Between Angiogenesis Markers and Disease-free Survival [Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry]

    2. The Association Between Disease-free Survival and the Frequency of Oncogene as Well as Tumor Suppressor Gene Mutations [Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry]

    3. The Association Between Tumor and Genetic Polymorphisms and Disease-free Survival [Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry]

    4. The Association Between Deoxyribonucleic Acid (DNA) Methylation Profiles and Disease-free Survival [Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry]

    5. The Relationship of Polymorphisms in Drug Metabolizing Enzymes With Steady State Concentrations of Sorafenib and Sunitinib in Selected Patients [Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry]

    6. The Effect of Vascular Endothelial Growth Factor (VEGF) Targeted Therapy on Circulating Endothelial Cells and Circulating Endothelial Progenitors [Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry]

    7. Patient-reported Fatigue Using Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale [Assessed at baseline, 10 weeks and 22 weeks]

    8. Patient-reported Fatigue Using the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form [Assessed at baseline, 10 weeks and 22 weeks]

      PROMIS Fatigue short form is a newly developed state-of-the-science PROMIS measure for fatigue

    9. The Association Between Scan Frequency and Development of Congestive Heart Failure [Assessed at 3, 6 and 12 months]

    10. Frequency of Clinically Significant Congestive Heart Failure (CHF) Grade 3 or Higher Using the Common Terminology Criteria for Adverse Events Version 4.0 [Assessed every 6 weeks while on treatment and for 30 days after the end of treatment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Pre-surgical criteria:

    • Patients must have primary-intact renal cell carcinoma, eligible for nephrectomy with curative intent

    • Tumors >= 4 cm AND/OR macroscopic fully resectable nodes AND/OR surgically resectable renal vein thrombus AND/OR surgically resectable inferior vena caval thrombus by radiologic criteria to be clinically >= pT1bNany (resectable) M0 disease

    • Multifocal ipsilateral renal cell carcinoma is allowed provided fully resectable and does not exceed inclusion criteria

    • Patients must have no history of distant metastases

    • No prior anti-cancer therapy for renal cell carcinoma is permitted in either the adjuvant or neoadjuvant setting; this includes metastectomy for renal cell carcinoma, or radiation therapy to the renal bed

    • Patients must not have other current malignancies, other than basal cell skin cancer, squamous cell skin cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast; patients with other malignancies are eligible if they have been continuously disease-free for >= 5 years prior to the time of registration

    • Patients must have no serious intercurrent illness including, but not limited to, the following: clinically significant cardiovascular disease (e.g. uncontrolled hypertension, myocardial infarction, unstable angina); New York Heart Association grade II or greater congestive heart failure; serious cardiac arrhythmia requiring medication; grade II or greater peripheral vascular disease; or psychiatric illness/social situations that would limit compliance with study requirements

    • Patients must not have any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism

    • Patient must not have ongoing ventricular cardiac dysrhythmias of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 grade

    = 2; patients with a history of serious ventricular arrhythmia (ventricular tachycardia [VT] or ventricular fibrillation [VF] >= 3 beats in a row) are also excluded; additionally, patients with ongoing atrial fibrillation are not eligible

    • Patients must have corrected QT (QTc) interval < 500 msec on baseline electrocardiogram (EKG)

    • Patient must not have hypertension that cannot be controlled by medications (>= diastolic blood pressure 100 mm Hg despite optimal medical therapy)

    • Patient must not have pre-existing thyroid abnormality with thyroid stimulating hormone that cannot be maintained in the normal range with medication

    • If female, patient must not be pregnant or breastfeeding; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to pre-registration to rule out pregnancy; if pre-registration occurs prior to surgery, the blood or urine study must be repeated within 2 weeks prior to randomization to rule out pregnancy; (note: should a woman become pregnant while participating in this study, she should inform her treating physician immediately)

    • Women of child-bearing potential and men must agree to use an accepted and effective method of contraception prior to study entry and for the duration of study participation; should a woman become pregnant while participating in this study, she should inform her treating physician immediately; if a man impregnates a woman while participating in this study, he should inform his treating physician immediately as well

    • Patients with known human immunodeficiency virus (HIV) are excluded

    • ELIGIBILITY CRITERIA FOLLOWING RADICAL OR PARTIAL NEPHRECTOMY

    • The date of randomization must be less than 12 weeks after the date of surgery; patients must have recovered from any surgical related complications

    • Within 4 weeks prior to randomization, patients must meet preoperative eligibility requirements

    • Patients must have histologically or cytologically confirmed renal cell carcinoma. Using 2002 (American Joint Committee on Cancer [AJCC] 6th edition) TNM Staging, patients must be one of the following:

    • pT1b G3-4 N0 (or pNX where clinically N0) M0

    • pT2 G (any) N0 (or pNX where clinically N0) M0

    • pT3 G (any) N0 (or pNX where clinically N0) M0

    • pT4 G (any) N0 (or pNX where clinically N0) M0 or

    • T (any) G (any) N+ (fully resected) M0

    • Patients with microvascular invasion of the renal vein of any grade or stage (as long as M0) are also eligible

    • Patients must have undergone a full surgical resection (radical nephrectomy or partial nephrectomy) by either open or laparoscopic technique; clinical evidence of lymph node positivity requires removal of all clinically positive nodes; surgeons should designate extent of node dissection; all surgical specimens must have negative margins; patients with positive renal vein margins are eligible unless there is invasion of the renal vein wall at the margin (provided no other margins are positive)

    • Patients must not have collecting duct carcinomas or medullary carcinomas

    • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

    • Patients must have an absolute baseline left ventricular ejection fraction (LVEF) of

    = 50% by multigated acquisition (MUGA) scan within 4 weeks prior to randomization

    • Patients must have paraffin-embedded tumor specimen available for central core review of tumor histology and other correlative studies; tumor samples will be shipped as specified

    • Patients must have no evidence of residual or metastatic renal cell cancer as documented on computed tomography (CT) scans of the chest, abdomen, and pelvis, all with oral and intravenous (IV) contrast (magnetic resonance imaging [MRI] scans of the abdomen and pelvis with gadolinium and a non-contrast CT of the chest may be substituted if patient is not able to have CT scans with intravenous contrast); patients unable to tolerate either gadolinium or IV contrast should not participate in this study (limitations to a patient's renal function should be taken into consideration when screening for this study)

    • Scans must be obtained within 4 weeks of randomization; changes on these scans that are felt to be post surgical must be documented

    • Patients without reported lymph nodes in the resected surgical specimen and a reported pathologic stage (post-nephrectomy) of pNX MUST undergo a post-operative contrast-enhanced CT scan (or MRI with gadolinium) within 4 weeks of randomization to document that there is no evidence of residual disease

    • Patients must not be taking cytochrome P450 enzyme-inducing antiepileptic drugs (phenytoin, carbamazepine or phenobarbital), St John's Wort, ketoconazole, dexamethasone, the dysrhythmic drugs (terfenadine, quinidine, procainamide, sotalol, probucol, bepridil, indapamide or flecainide), haloperidol, risperidone, rifampin, grapefruit, or grapefruit juice within two weeks of randomization and during the course of therapy; (medications are not prohibited unless listed above); topical and inhaled steroids are permitted

    • Patients must not receive any other investigational anti-cancer agents during the period on study

    • Patients must not have a serious intercurrent illness, including ongoing or active infection requiring parental antibiotics

    • Absolute granulocyte count (AGC) >= 1,500/mm^3

    • Platelet count >= 100,000/mm^3

    • Serum creatinine =< 2.0 x upper limit of normal (ULN) or calculated creatinine clearance (CrCl) >= 30 mL/min (neither drug is cleared by the kidney)

    • Total bilirubin =< 1.5 x upper limit of normal (ULN)

    • Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) =< 2.5 x ULN

    • Patients must be able to swallow pills

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Cancer Center Birmingham Alabama United States 35233
    2 Clearview Cancer Institute Huntsville Alabama United States 35805
    3 Mobile Infirmary Medical Center Mobile Alabama United States 36607
    4 Providence Hospital Mobile Alabama United States 36608
    5 University of South Alabama Mitchell Cancer Institute Mobile Alabama United States 36688
    6 Providence Alaska Medical Center Anchorage Alaska United States 99508
    7 Fairbanks Memorial Hospital Fairbanks Alaska United States 99701
    8 Banner Thunderbird Medical Center Glendale Arizona United States 85306
    9 Banner-University Medical Center Phoenix Phoenix Arizona United States 85006
    10 Western Regional CCOP Phoenix Arizona United States 85006
    11 Mayo Clinic in Arizona Scottsdale Arizona United States 85259
    12 Banner University Medical Center - Tucson Tucson Arizona United States 85719
    13 Sparks Regional Medical Center Fort Smith Arkansas United States 72901
    14 CHI Saint Vincent Cancer Center Hot Springs Hot Springs Arkansas United States 71913
    15 University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
    16 Highlands Oncology Group-Rogers Rogers Arkansas United States 72758
    17 Alta Bates Summit Medical Center-Herrick Campus Berkeley California United States 94704
    18 Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California United States 91505
    19 Mills-Peninsula Medical Center Burlingame California United States 94010
    20 East Bay Radiation Oncology Center Castro Valley California United States 94546
    21 Eden Hospital Medical Center Castro Valley California United States 94546
    22 Valley Medical Oncology Consultants-Castro Valley Castro Valley California United States 94546
    23 John Muir Medical Center-Concord Campus Concord California United States 94520
    24 City of Hope Comprehensive Cancer Center Duarte California United States 91010
    25 Bay Area Breast Surgeons Inc Emeryville California United States 94608
    26 Kaiser Permanente-Fremont Fremont California United States 94538
    27 Valley Medical Oncology Consultants-Fremont Fremont California United States 94538
    28 Washington Hospital Fremont California United States 94538
    29 Saint Jude Medical Center Fullerton California United States 92835
    30 Glendale Memorial Hospital and Health Center Glendale California United States 91204
    31 Marin Cancer Care Inc Greenbrae California United States 94904
    32 Marin General Hospital Greenbrae California United States 94904
    33 Saint Rose Hospital Hayward California United States 94545
    34 Loma Linda University Medical Center Loma Linda California United States 92354
    35 Veterans Affairs Loma Linda Healthcare System Loma Linda California United States 92357
    36 USC / Norris Comprehensive Cancer Center Los Angeles California United States 90033
    37 Contra Costa Regional Medical Center Martinez California United States 94553-3156
    38 Fremont - Rideout Cancer Center Marysville California United States 95901
    39 Memorial Medical Center Modesto California United States 95355
    40 Community Hospital of Monterey Peninsula Monterey California United States 93940
    41 El Camino Hospital Mountain View California United States 94040
    42 Palo Alto Medical Foundation-Camino Division Mountain View California United States 94040
    43 Northridge Hospital Medical Center Northridge California United States 91325
    44 Sutter Cancer Research Consortium Novato California United States 94945
    45 Highland General Hospital Oakland California United States 94602
    46 Alta Bates Summit Medical Center - Summit Campus Oakland California United States 94609
    47 Bay Area Tumor Institute Oakland California United States 94609
    48 Hematology and Oncology Associates-Oakland Oakland California United States 94609
    49 Tom K Lee Inc Oakland California United States 94609
    50 Kaiser Permanente-Oakland Oakland California United States 94611
    51 Saint Joseph Hospital - Orange Orange California United States 92868
    52 UC Irvine Health/Chao Family Comprehensive Cancer Center Orange California United States 92868
    53 Palo Alto Medical Foundation Health Care Palo Alto California United States 94301
    54 Stanford Cancer Institute Palo Alto Palo Alto California United States 94304
    55 VA Palo Alto Health Care System Palo Alto California United States 94304
    56 Valley Care Health System - Pleasanton Pleasanton California United States 94588
    57 Valley Medical Oncology Consultants Pleasanton California United States 94588
    58 Eisenhower Medical Center Rancho Mirage California United States 92270
    59 Shasta Regional Medical Center Redding California United States 96001
    60 Kaiser Permanente-Redwood City Redwood City California United States 94063
    61 Kaiser Permanente-Richmond Richmond California United States 94801
    62 Kaiser Permanente-Roseville Roseville California United States 95661
    63 Sutter Roseville Medical Center Roseville California United States 95661
    64 Sutter Medical Center Sacramento Sacramento California United States 95816
    65 University of California Davis Comprehensive Cancer Center Sacramento California United States 95817
    66 Mercy General Hospital Sacramento California United States 95819
    67 Kaiser Permanente-South Sacramento Sacramento California United States 95823
    68 Kaiser Permanente - Sacramento Sacramento California United States 95825
    69 Salinas Valley Memorial Salinas California United States 93901
    70 University of California San Diego San Diego California United States 92103
    71 Kaiser Permanente-San Diego Mission San Diego California United States 92108
    72 Veterans Administration-San Diego Medical Center San Diego California United States 92161
    73 California Pacific Medical Center-Pacific Campus San Francisco California United States 94115
    74 Kaiser Permanente-San Francisco San Francisco California United States 94115
    75 UCSF Medical Center-Mount Zion San Francisco California United States 94115
    76 Kaiser Permanente-Santa Teresa-San Jose San Jose California United States 95119
    77 Kaiser Permanente San Leandro San Leandro California United States 94577
    78 Doctors Medical Center- JC Robinson Regional Cancer Center San Pablo California United States 94806
    79 Kaiser Permanente-San Rafael San Rafael California United States 94903
    80 Kaiser Permanente Medical Center - Santa Clara Santa Clara California United States 95051
    81 Kaiser Permanente-Santa Rosa Santa Rosa California United States 95403
    82 Kaiser Permanente-South San Francisco South San Francisco California United States 94080
    83 Kaiser Permanente-Stockton Stockton California United States 95210
    84 Gene Upshaw Memorial Tahoe Forest Cancer Center Truckee California United States 96161
    85 Northbay Cancer Center Vacaville California United States 95687
    86 Kaiser Permanente-Vallejo Vallejo California United States 94589
    87 Sutter Solano Medical Center/Cancer Center Vallejo California United States 94589
    88 Kaiser Permanente-Walnut Creek Walnut Creek California United States 94596
    89 John Muir Medical Center-Walnut Creek Walnut Creek California United States 94598
    90 The Medical Center of Aurora Aurora Colorado United States 80012
    91 Rocky Mountain Regional VA Medical Center Aurora Colorado United States 80045
    92 Boulder Community Hospital Boulder Colorado United States 80301
    93 Penrose-Saint Francis Healthcare Colorado Springs Colorado United States 80907
    94 UCHealth Memorial Hospital Central Colorado Springs Colorado United States 80909
    95 Denver Health Medical Center Denver Colorado United States 80204
    96 Kaiser Permanente-Franklin Denver Colorado United States 80205
    97 Porter Adventist Hospital Denver Colorado United States 80210
    98 University of Colorado Denver Colorado United States 80217-3364
    99 Presbyterian - Saint Lukes Medical Center - Health One Denver Colorado United States 80218
    100 SCL Health Saint Joseph Hospital Denver Colorado United States 80218
    101 Rose Medical Center Denver Colorado United States 80220
    102 Colorado Cancer Research Program NCORP Denver Colorado United States 80222
    103 Shaw Cancer Center Edwards Colorado United States 81632
    104 Swedish Medical Center Englewood Colorado United States 80113
    105 Poudre Valley Hospital Fort Collins Colorado United States 80524
    106 Valley View Hospital Cancer Center Glenwood Springs Colorado United States 81601
    107 Saint Mary's Hospital and Regional Medical Center Grand Junction Colorado United States 81501
    108 North Colorado Medical Center Greeley Colorado United States 80631
    109 Kaiser Permanente-Rock Creek Lafayette Colorado United States 80026
    110 Saint Anthony Hospital Lakewood Colorado United States 80228
    111 Sky Ridge Medical Center Lone Tree Colorado United States 80124
    112 Longmont United Hospital Longmont Colorado United States 80501
    113 McKee Medical Center Loveland Colorado United States 80539
    114 Montrose Memorial Hospital Montrose Colorado United States 81401
    115 Saint Mary Corwin Medical Center Pueblo Colorado United States 81004
    116 North Suburban Medical Center Thornton Colorado United States 80229
    117 SCL Health Lutheran Medical Center Wheat Ridge Colorado United States 80033
    118 Saint Vincent's Medical Center Bridgeport Connecticut United States 06606
    119 Danbury Hospital Danbury Connecticut United States 06810
    120 Hartford Hospital Hartford Connecticut United States 06102
    121 Smilow Cancer Hospital Care Center at Saint Francis Hartford Connecticut United States 06105
    122 Manchester Memorial Hospital Manchester Connecticut United States 06040
    123 Yale University New Haven Connecticut United States 06520
    124 Norwalk Hospital Norwalk Connecticut United States 06856
    125 Eastern Connecticut Hematology and Oncology Associates Norwich Connecticut United States 06360
    126 Bayhealth Hospital Kent Campus Dover Delaware United States 19901
    127 Beebe Medical Center Lewes Delaware United States 19958
    128 Christiana Care Health System-Christiana Hospital Newark Delaware United States 19718
    129 MedStar Georgetown University Hospital Washington District of Columbia United States 20007
    130 MedStar Washington Hospital Center Washington District of Columbia United States 20010
    131 Sibley Memorial Hospital Washington District of Columbia United States 20016
    132 George Washington University Medical Center Washington District of Columbia United States 20037
    133 Boca Raton Regional Hospital Boca Raton Florida United States 33486
    134 Holy Cross Hospital Fort Lauderdale Florida United States 33308
    135 Broward Health Medical Center Fort Lauderdale Florida United States 33316
    136 Lee Memorial Health System Fort Myers Florida United States 33901
    137 Southwest Florida Regional Medical Center Fort Myers Florida United States 33901
    138 Florida Cancer Specialists-Gainesville Cancer Center Gainesville Florida United States 32605
    139 University of Florida Health Science Center - Gainesville Gainesville Florida United States 32610
    140 Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood Florida United States 33021
    141 Baptist MD Anderson Cancer Center Jacksonville Florida United States 32207
    142 Mayo Clinic in Florida Jacksonville Florida United States 32224-9980
    143 Jupiter Medical Center Jupiter Florida United States 33458
    144 Lakeland Regional Health Hollis Cancer Center Lakeland Florida United States 33805
    145 Cancer Centers of Central Florida PA Leesburg Florida United States 34788
    146 Mount Sinai Medical Center Miami Beach Florida United States 33140
    147 University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida United States 33136
    148 21st Century Oncology-Orange Park Orange Park Florida United States 32073
    149 AdventHealth Orlando Orlando Florida United States 32803
    150 UF Cancer Center at Orlando Health Orlando Florida United States 32806
    151 Sacred Heart Hospital Pensacola Florida United States 32504
    152 Florida Cancer Specialists - Sarasota Downtown Sarasota Florida United States 34236
    153 Moffitt Cancer Center Tampa Florida United States 33612
    154 Cleveland Clinic-Weston Weston Florida United States 33331
    155 Phoebe Putney Memorial Hospital Albany Georgia United States 31701
    156 University Cancer and Blood Center LLC Athens Georgia United States 30607
    157 Piedmont Hospital Atlanta Georgia United States 30309
    158 Emory University Hospital/Winship Cancer Institute Atlanta Georgia United States 30322
    159 Atlanta Regional CCOP Atlanta Georgia United States 30342
    160 Emory Saint Joseph's Hospital Atlanta Georgia United States 30342
    161 Northside Hospital Atlanta Georgia United States 30342
    162 Augusta University Medical Center Augusta Georgia United States 30912
    163 WellStar Cobb Hospital Austell Georgia United States 30106
    164 John B Amos Cancer Center Columbus Georgia United States 31904
    165 Atlanta VA Medical Center Decatur Georgia United States 30033
    166 Dekalb Medical Center Decatur Georgia United States 30033
    167 Northeast Georgia Medical Center-Gainesville Gainesville Georgia United States 30501
    168 Gwinnett Medical Center Lawrenceville Georgia United States 30046
    169 Medical Center of Central Georgia Macon Georgia United States 31201
    170 Wellstar Kennestone Hospital Marietta Georgia United States 30060
    171 Southern Regional Medical Center Riverdale Georgia United States 30274
    172 Harbin Clinic Medical Oncology and Clinical Research Rome Georgia United States 30165
    173 Memorial Health University Medical Center Savannah Georgia United States 31404
    174 Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah Georgia United States 31405
    175 South Georgia Medical Center/Pearlman Cancer Center Valdosta Georgia United States 31602
    176 Pali Momi Medical Center 'Aiea Hawaii United States 96701
    177 Hawaii Cancer Care Inc-POB II Honolulu Hawaii United States 96813
    178 Queen's Medical Center Honolulu Hawaii United States 96813
    179 Straub Clinic and Hospital Honolulu Hawaii United States 96813
    180 University of Hawaii Cancer Center Honolulu Hawaii United States 96813
    181 Hawaii Oncology Inc-Kuakini Honolulu Hawaii United States 96817
    182 The Cancer Center of Hawaii-Liliha Honolulu Hawaii United States 96817
    183 Kaiser Permanente Moanalua Medical Center Honolulu Hawaii United States 96819
    184 Kapiolani Medical Center for Women and Children Honolulu Hawaii United States 96826
    185 Tripler Army Medical Center Honolulu Hawaii United States 96859
    186 Maui Memorial Medical Center Wailuku Hawaii United States 96793
    187 Pacific Cancer Institute of Maui Wailuku Hawaii United States 96793
    188 Saint Alphonsus Cancer Care Center-Boise Boise Idaho United States 83706
    189 Portneuf Medical Center Pocatello Idaho United States 83201
    190 Kootenai Cancer Center Post Falls Idaho United States 83854
    191 Saint Anthony's Health Alton Illinois United States 62002
    192 Rush - Copley Medical Center Aurora Illinois United States 60504
    193 Saint Joseph Medical Center Bloomington Illinois United States 61701
    194 Illinois CancerCare-Bloomington Bloomington Illinois United States 61704
    195 Graham Hospital Association Canton Illinois United States 61520
    196 Illinois CancerCare-Canton Canton Illinois United States 61520
    197 Illinois CancerCare-Carthage Carthage Illinois United States 62321
    198 Memorial Hospital Carthage Illinois United States 62321
    199 Mount Sinai Hospital Medical Center Chicago Illinois United States 60608
    200 Hematology and Oncology Associates Chicago Illinois United States 60611
    201 Northwestern University Chicago Illinois United States 60611
    202 Jesse Brown Veterans Affairs Medical Center Chicago Illinois United States 60612
    203 John H Stroger Jr Hospital of Cook County Chicago Illinois United States 60612
    204 Rush University Medical Center Chicago Illinois United States 60612
    205 Mercy Hospital and Medical Center Chicago Illinois United States 60616
    206 Swedish Covenant Hospital Chicago Illinois United States 60625
    207 Presence Resurrection Medical Center Chicago Illinois United States 60631
    208 University of Chicago Comprehensive Cancer Center Chicago Illinois United States 60637
    209 Decatur Memorial Hospital Decatur Illinois United States 62526
    210 Heartland Cancer Research NCORP Decatur Illinois United States 62526
    211 Advocate Sherman Hospital Elgin Illinois United States 60123
    212 AMITA Health Alexian Brothers Medical Center Elk Grove Village Illinois United States 60007
    213 Elmhurst Memorial Hospital Elmhurst Illinois United States 60126
    214 Eureka Hospital Eureka Illinois United States 61530
    215 Illinois CancerCare-Eureka Eureka Illinois United States 61530
    216 NorthShore University HealthSystem-Evanston Hospital Evanston Illinois United States 60201
    217 Saint Francis Hospital Evanston Illinois United States 60202
    218 Galesburg Cottage Hospital Galesburg Illinois United States 61401
    219 Illinois CancerCare-Cottage Galesburg Illinois United States 61401
    220 Illinois CancerCare-Galesburg Galesburg Illinois United States 61401
    221 LaGrange Oncology Associates Geneva Illinois United States 60134
    222 Northwestern Medicine Cancer Center Delnor Geneva Illinois United States 60134
    223 Ingalls Memorial Hospital Harvey Illinois United States 60426
    224 Illinois CancerCare-Havana Havana Illinois United States 62644
    225 Mason District Hospital Havana Illinois United States 62644
    226 Hematology Oncology Associates of Illinois-Highland Park Highland Park Illinois United States 60035
    227 Hinsdale Hematology Oncology Associates Incorporated Hinsdale Illinois United States 60521
    228 Hopedale Medical Complex - Hospital Hopedale Illinois United States 61747
    229 Midwest Center for Hematology Oncology Joliet Illinois United States 60432
    230 Joliet Oncology-Hematology Associates Limited Joliet Illinois United States 60435
    231 Presence Saint Mary's Hospital Kankakee Illinois United States 60901
    232 Illinois CancerCare-Kewanee Clinic Kewanee Illinois United States 61443
    233 Kewanee Hospital Kewanee Illinois United States 61443
    234 AMITA Health Adventist Medical Center La Grange Illinois United States 60525
    235 NorthShore Hematology Oncology-Libertyville Libertyville Illinois United States 60048
    236 Illinois CancerCare-Macomb Macomb Illinois United States 61455
    237 Mcdonough District Hospital Macomb Illinois United States 61455
    238 Loyola University Medical Center Maywood Illinois United States 60153
    239 Garneau, Stewart C MD (UIA Investigator) Moline Illinois United States 61265
    240 Porubcin, Michael MD (UIA Investigator) Moline Illinois United States 61265
    241 Sharis, Christine M MD (UIA Investigator) Moline Illinois United States 61265
    242 Spector, David MD (UIA Investigator) Moline Illinois United States 61265
    243 Stoffel, Thomas J MD (UIA Investigator) Moline Illinois United States 61265
    244 Trinity Medical Center Moline Illinois United States 61265
    245 Vigliotti, Antonio, P.G. M.D. (UIA Investigator) Moline Illinois United States 61265
    246 Holy Family Medical Center Monmouth Illinois United States 61462
    247 Illinois CancerCare-Monmouth Monmouth Illinois United States 61462
    248 Good Samaritan Regional Health Center Mount Vernon Illinois United States 62864
    249 Edward Hospital/Cancer Center Naperville Illinois United States 60540
    250 DuPage Medical Group-Ogden Naperville Illinois United States 60563
    251 Illinois Cancer Specialists-Niles Niles Illinois United States 60714
    252 Bromenn Regional Medical Center Normal Illinois United States 61761
    253 Community Cancer Center Foundation Normal Illinois United States 61761
    254 Illinois CancerCare-Community Cancer Center Normal Illinois United States 61761
    255 Advocate Christ Medical Center Oak Lawn Illinois United States 60453-2699
    256 Franciscan St. James Health-Olympia Fields Campus Olympia Fields Illinois United States 60461
    257 Illinois CancerCare-Ottawa Clinic Ottawa Illinois United States 61350
    258 Ottawa Regional Hospital and Healthcare Center Ottawa Illinois United States 61350
    259 Illinois CancerCare-Pekin Pekin Illinois United States 61554
    260 OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center Pekin Illinois United States 61554
    261 Pekin Hospital Pekin Illinois United States 61554
    262 Proctor Hospital Peoria Illinois United States 61614
    263 Illinois CancerCare-Peoria Peoria Illinois United States 61615
    264 Methodist Medical Center of Illinois Peoria Illinois United States 61636
    265 OSF Saint Francis Medical Center Peoria Illinois United States 61637
    266 Illinois CancerCare-Peru Peru Illinois United States 61354
    267 Illinois Valley Hospital Peru Illinois United States 61354
    268 Illinois CancerCare-Princeton Princeton Illinois United States 61356
    269 Perry Memorial Hospital Princeton Illinois United States 61356
    270 West Suburban Medical Center River Forest Illinois United States 60305
    271 Swedish American Hospital Rockford Illinois United States 61104
    272 OSF Saint Anthony Medical Center Rockford Illinois United States 61108
    273 Edward H Kaplan MD and Associates Skokie Illinois United States 60076
    274 Hematology Oncology Associates of Illinois - Skokie Skokie Illinois United States 60076
    275 Illinois CancerCare-Spring Valley Spring Valley Illinois United States 61362
    276 Saint Margaret's Hospital Spring Valley Illinois United States 61362
    277 Memorial Medical Center Springfield Illinois United States 62781
    278 Carle Cancer Center Urbana Illinois United States 61801
    279 Northwestern Medicine Central DuPage Hospital Winfield Illinois United States 60190
    280 Franciscan Saint Francis Health-Beech Grove Beech Grove Indiana United States 46107
    281 Elkhart Clinic Elkhart Indiana United States 46514-2098
    282 Elkhart General Hospital Elkhart Indiana United States 46515
    283 Fort Wayne Medical Oncology and Hematology Inc-Parkview Fort Wayne Indiana United States 46845
    284 Goshen Center for Cancer Care Goshen Indiana United States 46526
    285 Indiana University/Melvin and Bren Simon Cancer Center Indianapolis Indiana United States 46202
    286 Richard L. Roudebush Veterans Affairs Medical Center Indianapolis Indiana United States 46202
    287 Sidney and Lois Eskenazi Hospital Indianapolis Indiana United States 46202
    288 Saint Vincent Hospital and Health Care Center Indianapolis Indiana United States 46260
    289 Community Howard Regional Health Kokomo Indiana United States 46904
    290 IU Health La Porte Hospital La Porte Indiana United States 46350
    291 IU Health Arnett Cancer Care Lafayette Indiana United States 47904
    292 Horizon Oncology Research LLC Lafayette Indiana United States 47905
    293 Premier Oncology Hematology Associates Merrillville Indiana United States 46410
    294 Franciscan Saint Anthony Health-Michigan City Michigan City Indiana United States 46360
    295 Saint Joseph Regional Medical Center-Mishawaka Mishawaka Indiana United States 46545
    296 The Community Hospital Munster Indiana United States 46321
    297 Reid Health Richmond Indiana United States 47374
    298 Memorial Hospital of South Bend South Bend Indiana United States 46601
    299 Michiana Hematology Oncology PC-South Bend South Bend Indiana United States 46601
    300 South Bend Clinic South Bend Indiana United States 46617
    301 Northern Indiana Cancer Research Consortium South Bend Indiana United States 46628
    302 McFarland Clinic PC - Ames Ames Iowa United States 50010
    303 Constantinou, Costas L MD (UIA Investigator) Bettendorf Iowa United States 52722
    304 University of Iowa Healthcare Cancer Services Quad Cities Bettendorf Iowa United States 52722
    305 Saint Luke's Hospital Cedar Rapids Iowa United States 52402
    306 Mercy Hospital Cedar Rapids Iowa United States 52403
    307 Oncology Associates at Mercy Medical Center Cedar Rapids Iowa United States 52403
    308 Medical Oncology and Hematology Associates-West Des Moines Clive Iowa United States 50325
    309 Alegent Health Mercy Hospital Council Bluffs Iowa United States 51503
    310 Heartland Oncology and Hematology LLP Council Bluffs Iowa United States 51503
    311 Genesis Medical Center - East Campus Davenport Iowa United States 52803
    312 Genesis Cancer Care Institute Davenport Iowa United States 52804
    313 Mercy Capitol Des Moines Iowa United States 50307
    314 Iowa Methodist Medical Center Des Moines Iowa United States 50309
    315 Iowa-Wide Oncology Research Coalition NCORP Des Moines Iowa United States 50309
    316 Medical Oncology and Hematology Associates-Des Moines Des Moines Iowa United States 50309
    317 Medical Oncology and Hematology Associates-Laurel Des Moines Iowa United States 50314
    318 Mercy Medical Center - Des Moines Des Moines Iowa United States 50314
    319 Iowa Lutheran Hospital Des Moines Iowa United States 50316
    320 University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa United States 52242
    321 Mercy Medical Center - North Iowa Mason City Iowa United States 50401
    322 Ottumwa Regional Health Center Ottumwa Iowa United States 52501
    323 Siouxland Regional Cancer Center Sioux City Iowa United States 51101
    324 Mercy Medical Center-Sioux City Sioux City Iowa United States 51102
    325 Saint Luke's Regional Medical Center Sioux City Iowa United States 51104
    326 Cedar Valley Medical Specialists Waterloo Iowa United States 50701
    327 MercyOne Waterloo Medical Center Waterloo Iowa United States 50702
    328 Hospital District Sixth of Harper County Anthony Kansas United States 67003
    329 Cancer Center of Kansas - Chanute Chanute Kansas United States 66720
    330 Cancer Center of Kansas - Dodge City Dodge City Kansas United States 67801
    331 Cancer Center of Kansas - El Dorado El Dorado Kansas United States 67042
    332 Cancer Center of Kansas - Fort Scott Fort Scott Kansas United States 66701
    333 Hays Medical Center Hays Kansas United States 67601
    334 Hutchinson Regional Medical Center Hutchinson Kansas United States 67502
    335 Cancer Center of Kansas-Independence Independence Kansas United States 67301
    336 Providence Medical Center Kansas City Kansas United States 66112
    337 University of Kansas Cancer Center Kansas City Kansas United States 66160
    338 Cancer Center of Kansas-Kingman Kingman Kansas United States 67068
    339 Lawrence Memorial Hospital Lawrence Kansas United States 66044
    340 Southwest Medical Center Liberal Kansas United States 67901
    341 Cancer Center of Kansas - Newton Newton Kansas United States 67114
    342 Olathe Cancer Center Olathe Kansas United States 66061
    343 Menorah Medical Center Overland Park Kansas United States 66209
    344 Radiation Oncology Practice Corporation Southwest Overland Park Kansas United States 66210
    345 Saint Luke's South Hospital Overland Park Kansas United States 66213
    346 Cancer Center of Kansas - Parsons Parsons Kansas United States 67357
    347 Cancer Center of Kansas - Pratt Pratt Kansas United States 67124
    348 Cancer Center of Kansas - Salina Salina Kansas United States 67401
    349 Shawnee Mission Medical Center-KCCC Shawnee Mission Kansas United States 66204
    350 Cotton O'Neil Cancer Center / Stormont Vail Health Topeka Kansas United States 66606
    351 Saint Francis Hospital and Medical Center - Topeka Topeka Kansas United States 66606
    352 Cancer Center of Kansas - Wellington Wellington Kansas United States 67152
    353 Associates In Womens Health Wichita Kansas United States 67208
    354 Cancer Center of Kansas-Wichita Medical Arts Tower Wichita Kansas United States 67208
    355 Cancer Center of Kansas - Wichita Wichita Kansas United States 67214
    356 Via Christi Regional Medical Center Wichita Kansas United States 67214
    357 Wichita NCI Community Oncology Research Program Wichita Kansas United States 67214
    358 Cancer Center of Kansas - Winfield Winfield Kansas United States 67156
    359 University of Kentucky/Markey Cancer Center Lexington Kentucky United States 40536
    360 The James Graham Brown Cancer Center at University of Louisville Louisville Kentucky United States 40202
    361 Baptist Health Louisville Louisville Kentucky United States 40207
    362 Doctors Carrol, Sheth, Raghavan Louisville Kentucky United States 40215
    363 Baton Rouge General Medical Center Baton Rouge Louisiana United States 70806
    364 Mary Bird Perkins Cancer Center Baton Rouge Louisiana United States 70809
    365 Ochsner Health Center-Summa Baton Rouge Louisiana United States 70809
    366 University Health-Conway Monroe Louisiana United States 71202
    367 Louisiana State University Health Science Center New Orleans Louisiana United States 70112
    368 University Medical Center New Orleans New Orleans Louisiana United States 70112
    369 Ochsner Medical Center Jefferson New Orleans Louisiana United States 70121
    370 Louisiana State University Health Sciences Center Shreveport Shreveport Louisiana United States 71103
    371 Highland Clinic Shreveport Louisiana United States 71105
    372 Harold Alfond Center for Cancer Care Augusta Maine United States 04330
    373 Eastern Maine Medical Center Bangor Maine United States 04401
    374 Mercy Hospital Portland Maine United States 04101
    375 Maine Center for Cancer Medicine-Scarborough Scarborough Maine United States 04074
    376 Maine Medical Center- Scarborough Campus Scarborough Maine United States 04074
    377 Maine General Medical Center-Thayer Waterville Maine United States 04901
    378 York Hospital York Maine United States 03909
    379 Anne Arundel Medical Center Annapolis Maryland United States 21401
    380 University of Maryland/Greenebaum Cancer Center Baltimore Maryland United States 21201
    381 Greater Baltimore Medical Center Baltimore Maryland United States 21204
    382 Saint Agnes Hospital Baltimore Maryland United States 21229
    383 MedStar Franklin Square Medical Center/Weinberg Cancer Institute Baltimore Maryland United States 21237
    384 Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore Maryland United States 21287
    385 Suburban Hospital Bethesda Maryland United States 20814
    386 Memorial Hospital at Easton - Shore Regional Cancer Center Easton Maryland United States 21601
    387 University of Maryland Shore Medical Center at Easton Easton Maryland United States 21601
    388 Union Hospital of Cecil County Elkton Maryland United States 21921
    389 Frederick Memorial Hospital Frederick Maryland United States 21701
    390 Peninsula Regional Medical Center Salisbury Maryland United States 21801
    391 UM Saint Joseph Medical Center Towson Maryland United States 21204
    392 Massachusetts General Hospital Cancer Center Boston Massachusetts United States 02114
    393 Boston Medical Center Boston Massachusetts United States 02118
    394 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
    395 Dana-Farber Cancer Institute Boston Massachusetts United States 02215
    396 Steward Saint Elizabeth's Medical Center Brighton Massachusetts United States 02135
    397 Lahey Hospital and Medical Center Burlington Massachusetts United States 01805
    398 Addison Gilbert Hospital Gloucester Massachusetts United States 01930
    399 Cape Cod Hospital Hyannis Massachusetts United States 02601
    400 Holy Family Hospital Methuen Massachusetts United States 01844
    401 Milford Regional Medical Center Milford Massachusetts United States 01757
    402 Berkshire Medical Center - Cancer Center Pittsfield Massachusetts United States 01201
    403 Commonwealth Hematology Oncology PC-Worcester Worcester Massachusetts United States 01605
    404 University of Massachusetts Medical School Worcester Massachusetts United States 01655
    405 Bixby Medical Center Adrian Michigan United States 49221
    406 Hickman Cancer Center Adrian Michigan United States 49221
    407 Michigan Cancer Research Consortium NCORP Ann Arbor Michigan United States 48106
    408 Saint Joseph Mercy Hospital Ann Arbor Michigan United States 48106
    409 University of Michigan Comprehensive Cancer Center Ann Arbor Michigan United States 48109
    410 Bronson Battle Creek Battle Creek Michigan United States 49017
    411 Spectrum Health Big Rapids Hospital Big Rapids Michigan United States 49307
    412 Beaumont Hospital ? Dearborn Dearborn Michigan United States 48124
    413 Wayne State University/Karmanos Cancer Institute Detroit Michigan United States 48201
    414 Henry Ford Hospital Detroit Michigan United States 48202
    415 Ascension Saint John Hospital Detroit Michigan United States 48236
    416 Green Bay Oncology - Escanaba Escanaba Michigan United States 49829
    417 Hurley Medical Center Flint Michigan United States 48503
    418 Genesys Regional Medical Center-West Flint Campus Flint Michigan United States 48532
    419 McLaren Cancer Institute-Flint Flint Michigan United States 48532
    420 Cancer Research Consortium of West Michigan NCORP Grand Rapids Michigan United States 49503
    421 Mercy Health Saint Mary's Grand Rapids Michigan United States 49503
    422 Spectrum Health at Butterworth Campus Grand Rapids Michigan United States 49503
    423 Holland Community Hospital Holland Michigan United States 49423
    424 Green Bay Oncology - Iron Mountain Iron Mountain Michigan United States 49801
    425 Allegiance Health Jackson Michigan United States 49201
    426 Bronson Methodist Hospital Kalamazoo Michigan United States 49007
    427 West Michigan Cancer Center Kalamazoo Michigan United States 49007
    428 Borgess Medical Center Kalamazoo Michigan United States 49048
    429 Sparrow Hospital Lansing Michigan United States 48912
    430 Saint Mary Mercy Hospital Livonia Michigan United States 48154
    431 Mercy Memorial Hospital Monroe Michigan United States 48162
    432 Toledo Clinic Cancer Centers-Monroe Monroe Michigan United States 48162
    433 Mercy Health Partners-Hackley Campus Muskegon Michigan United States 49442
    434 Mercy Health Mercy Campus Muskegon Michigan United States 49444
    435 Saint Joseph Mercy Oakland Pontiac Michigan United States 48341
    436 Lake Huron Medical Center Port Huron Michigan United States 48060
    437 William Beaumont Hospital-Royal Oak Royal Oak Michigan United States 48073
    438 Ascension Saint Mary's Hospital Saginaw Michigan United States 48601
    439 Lakeland Medical Center Saint Joseph Saint Joseph Michigan United States 49085
    440 Marie Yeager Cancer Center Saint Joseph Michigan United States 49085
    441 Oncology Care Associates PLLC Saint Joseph Michigan United States 49085
    442 Ascension Providence Hospitals - Southfield Southfield Michigan United States 48075
    443 Munson Medical Center Traverse City Michigan United States 49684
    444 Saint John Macomb-Oakland Hospital Warren Michigan United States 48093
    445 Metro Health Hospital Wyoming Michigan United States 49519
    446 Harris, John Gilbert MD (UIA Investigator) Alexandria Minnesota United States 56308
    447 Medini, Eitan MD (UIA Investigator) Alexandria Minnesota United States 56308
    448 Sanford Joe Lueken Cancer Center Bemidji Minnesota United States 56601
    449 Brainerd Medical Center Inc Brainerd Minnesota United States 56401
    450 Essentia Health Saint Joseph's Medical Center Brainerd Minnesota United States 56401
    451 Fairview Ridges Hospital Burnsville Minnesota United States 55337
    452 Mercy Hospital Coon Rapids Minnesota United States 55433
    453 Essentia Health Cancer Center Duluth Minnesota United States 55805
    454 Essentia Health Saint Mary's Medical Center Duluth Minnesota United States 55805
    455 Miller-Dwan Hospital Duluth Minnesota United States 55805
    456 Fairview-Southdale Hospital Edina Minnesota United States 55435
    457 Etzell, Paul S MD (UIA Investigator) Fergus Falls Minnesota United States 56537
    458 Lake Region Healthcare Corporation-Cancer Care Fergus Falls Minnesota United States 56537
    459 Swenson, Wade II, MD (UIA Investigator) Fergus Falls Minnesota United States 56537
    460 Unity Hospital Fridley Minnesota United States 55432
    461 Hutchinson Area Health Care Hutchinson Minnesota United States 55350
    462 Meeker County Memorial Hospital Litchfield Minnesota United States 55355
    463 Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota United States 55109
    464 Saint John's Hospital - Healtheast Maplewood Minnesota United States 55109
    465 Abbott-Northwestern Hospital Minneapolis Minnesota United States 55407
    466 Virginia Piper Cancer Institute Minneapolis Minnesota United States 55407
    467 Hennepin County Medical Center Minneapolis Minnesota United States 55415
    468 Minneapolis VA Medical Center Minneapolis Minnesota United States 55417
    469 University of Minnesota/Masonic Cancer Center Minneapolis Minnesota United States 55455
    470 Chippewa County - Montevideo Hospital Montevideo Minnesota United States 56265
    471 North Memorial Medical Health Center Robbinsdale Minnesota United States 55422
    472 Mayo Clinic Rochester Minnesota United States 55905
    473 Coborn Cancer Center at Saint Cloud Hospital Saint Cloud Minnesota United States 56303
    474 Saint Cloud Hospital Saint Cloud Minnesota United States 56303
    475 Metro Minnesota Community Oncology Research Consortium Saint Louis Park Minnesota United States 55416
    476 Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota United States 55416
    477 Regions Hospital Saint Paul Minnesota United States 55101
    478 Saint Joseph's Hospital - Healtheast Saint Paul Minnesota United States 55102
    479 United Hospital Saint Paul Minnesota United States 55102
    480 Adult and Pediatric Urology PLLP Sartell Minnesota United States 56377
    481 Saint Francis Regional Medical Center Shakopee Minnesota United States 55379
    482 Ridgeview Medical Center Waconia Minnesota United States 55387
    483 Rice Memorial Hospital Willmar Minnesota United States 56201
    484 Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota United States 55125
    485 Woodwinds Health Campus Woodbury Minnesota United States 55125
    486 University of Mississippi Medical Center Jackson Mississippi United States 39216
    487 Singing River Hospital Pascagoula Mississippi United States 39581
    488 Southeast Missouri Hospital Cape Girardeau Missouri United States 63701
    489 Saint Francis Medical Center Cape Girardeau Missouri United States 63703
    490 Saint Luke's Hospital Chesterfield Missouri United States 63017
    491 Missouri Cancer Associates Columbia Missouri United States 65201
    492 Veterans Administration Columbia Missouri United States 65201
    493 University of Missouri - Ellis Fischel Columbia Missouri United States 65212
    494 Centerpoint Medical Center LLC Independence Missouri United States 64057
    495 Freeman Health System Joplin Missouri United States 64804
    496 Truman Medical Center Kansas City Missouri United States 64108
    497 Saint Luke's Hospital of Kansas City Kansas City Missouri United States 64111
    498 Radiation Oncology Practice Corporation South Kansas City Missouri United States 64114
    499 Saint Joseph Health Center Kansas City Missouri United States 64114
    500 North Kansas City Hospital Kansas City Missouri United States 64116
    501 Heartland Hematology and Oncology Associates Incorporated Kansas City Missouri United States 64118
    502 Research Medical Center Kansas City Missouri United States 64132
    503 Radiation Oncology Practice Corporation - North Kansas City Missouri United States 64154
    504 Saint Luke's East - Lee's Summit Lee's Summit Missouri United States 64086
    505 Liberty Radiation Oncology Center Liberty Missouri United States 64068
    506 Heartland Regional Medical Center Saint Joseph Missouri United States 64507
    507 Saint Joseph Oncology Inc Saint Joseph Missouri United States 64507
    508 Saint Louis Cancer and Breast Institute-South City Saint Louis Missouri United States 63109
    509 Saint Louis University Hospital Saint Louis Missouri United States 63110
    510 Washington University School of Medicine Saint Louis Missouri United States 63110
    511 Mercy Hospital South Saint Louis Missouri United States 63128
    512 Missouri Baptist Medical Center Saint Louis Missouri United States 63131
    513 Siteman Cancer Center at Christian Hospital Saint Louis Missouri United States 63136
    514 Center for Cancer Care and Research Saint Louis Missouri United States 63141
    515 Mercy Hospital Saint Louis Saint Louis Missouri United States 63141
    516 Saint Louis-Cape Girardeau CCOP Saint Louis Missouri United States 63141
    517 Cancer Research for the Ozarks NCORP Springfield Missouri United States 65804
    518 Mercy Hospital Springfield Springfield Missouri United States 65804
    519 CoxHealth South Hospital Springfield Missouri United States 65807
    520 Billings Clinic Cancer Center Billings Montana United States 59101
    521 Northern Rockies Radiation Oncology Center Billings Montana United States 59101
    522 Saint Vincent Healthcare Billings Montana United States 59101
    523 Montana Cancer Consortium NCORP Billings Montana United States 59102
    524 Saint Vincent Frontier Cancer Center Billings Montana United States 59102
    525 Deaconess Medical Center Billings Montana United States 59107
    526 Bozeman Deaconess Hospital Bozeman Montana United States 59715
    527 Saint James Community Hospital and Cancer Treatment Center Butte Montana United States 59701
    528 Benefis Healthcare- Sletten Cancer Institute Great Falls Montana United States 59405
    529 Berdeaux, Donald MD (UIA Investigator) Great Falls Montana United States 59405
    530 Great Falls Clinic Great Falls Montana United States 59405
    531 Northern Montana Hospital Havre Montana United States 59501
    532 Saint Peter's Community Hospital Helena Montana United States 59601
    533 Glacier Oncology PLLC Kalispell Montana United States 59901
    534 Kalispell Medical Oncology Kalispell Montana United States 59901
    535 Kalispell Regional Medical Center Kalispell Montana United States 59901
    536 Montana Cancer Specialists Missoula Montana United States 59802
    537 Saint Patrick Hospital - Community Hospital Missoula Montana United States 59802
    538 Community Medical Hospital Missoula Montana United States 59804
    539 Guardian Oncology and Center for Wellness Missoula Montana United States 59804
    540 CHI Health Saint Francis Grand Island Nebraska United States 68803
    541 CHI Health Good Samaritan Kearney Nebraska United States 68847
    542 Nebraska Cancer Research Center Lincoln Nebraska United States 68510
    543 Great Plains Health Callahan Cancer Center North Platte Nebraska United States 69101
    544 Missouri Valley Cancer Consortium Omaha Nebraska United States 68106
    545 Nebraska Methodist Hospital Omaha Nebraska United States 68114
    546 Alegent Health Immanuel Medical Center Omaha Nebraska United States 68122
    547 Alegent Health Bergan Mercy Medical Center Omaha Nebraska United States 68124
    548 Alegent Health Lakeside Hospital Omaha Nebraska United States 68130
    549 Creighton University Medical Center Omaha Nebraska United States 68131
    550 University of Nebraska Medical Center Omaha Nebraska United States 68198
    551 Midlands Community Hospital Papillion Nebraska United States 68046
    552 Carson-Tahoe Specialty Medical Center Carson City Nevada United States 89703
    553 University Medical Center of Southern Nevada Las Vegas Nevada United States 89102
    554 Nevada Cancer Research Foundation CCOP Las Vegas Nevada United States 89106
    555 Renown Regional Medical Center Reno Nevada United States 89502
    556 Cheshire Medical Center-Dartmouth-Hitchcock Keene Keene New Hampshire United States 03431
    557 Dartmouth Hitchcock Medical Center Lebanon New Hampshire United States 03756
    558 Frisbie Hospital Rochester New Hampshire United States 03867
    559 Ocean Medical Center Brick New Jersey United States 08724
    560 Cooper Hospital University Medical Center Camden New Jersey United States 08103
    561 Veterans Adminstration New Jersey Health Care System East Orange New Jersey United States 07018-1095
    562 Hunterdon Medical Center Flemington New Jersey United States 08822
    563 CentraState Medical Center Freehold New Jersey United States 07728
    564 Hackensack University Medical Center Hackensack New Jersey United States 07601
    565 The Cancer Institute of New Jersey Hamilton Hamilton New Jersey United States 08690
    566 Saint Barnabas Medical Center Livingston New Jersey United States 07039
    567 Monmouth Medical Center Long Branch New Jersey United States 07740
    568 Mountainside Hospital Montclair New Jersey United States 07042
    569 Morristown Medical Center Morristown New Jersey United States 07960
    570 Virtua Memorial Mount Holly New Jersey United States 08060
    571 Saint Peter's University Hospital New Brunswick New Jersey United States 08901
    572 Rutgers Cancer Institute of New Jersey New Brunswick New Jersey United States 08903
    573 Rutgers New Jersey Medical School Newark New Jersey United States 07101
    574 Capital Health Medical Center-Hopewell Pennington New Jersey United States 08534
    575 Riverview Medical Center/Booker Cancer Center Red Bank New Jersey United States 07701
    576 Valley Hospital Ridgewood New Jersey United States 07450
    577 Robert Wood Johnson University Hospital Somerset Somerville New Jersey United States 08876
    578 Overlook Hospital Summit New Jersey United States 07902
    579 Community Medical Center Toms River New Jersey United States 08755
    580 Inspira Medical Center Vineland Vineland New Jersey United States 08360
    581 Virtua Voorhees Voorhees New Jersey United States 08043
    582 University of New Mexico Cancer Center Albuquerque New Mexico United States 87102
    583 Hematology Oncology Associates Albuquerque New Mexico United States 87106
    584 Presbyterian Kaseman Hospital Albuquerque New Mexico United States 87110
    585 Memorial Medical Center - Las Cruces Las Cruces New Mexico United States 88011
    586 Christus Saint Vincent Regional Cancer Center Santa Fe New Mexico United States 87505
    587 Christus Saint Vincent Regional Medical Center Santa Fe New Mexico United States 87505
    588 New York Oncology Hematology PC - Albany Albany New York United States 12206
    589 New York Oncology Hematology PC -Albany Medical Center Albany New York United States 12208
    590 New York Oncology Hematology PC - Amsterdam Amsterdam New York United States 12010
    591 Montefiore Medical Center-Weiler Hospital Bronx New York United States 10461
    592 Montefiore Medical Center-Wakefield Campus Bronx New York United States 10466
    593 Montefiore Medical Center - Moses Campus Bronx New York United States 10467
    594 Kings County Hospital Brooklyn New York United States 11203
    595 State University of New York Downstate Medical Center Brooklyn New York United States 11203
    596 Veteran Affairs New York Harbor Healthcare System-Brooklyn Campus Brooklyn New York United States 11209
    597 Veterans Affairs Western New York Health Care System-Buffalo Buffalo New York United States 14215
    598 Roswell Park Cancer Institute Buffalo New York United States 14263
    599 New York Oncology Hematology PC - Clifton Park Clifton Park New York United States 12065
    600 Mary Imogene Bassett Hospital Cooperstown New York United States 13326
    601 Hematology Oncology Associates of Central New York-East Syracuse East Syracuse New York United States 13057
    602 Adirondack Cancer Center Glens Falls New York United States 12801
    603 Glens Falls Hospital Glens Falls New York United States 12801
    604 New York Oncology Hematology PC-Hudson Hudson New York United States 12534
    605 Northwell Health NCORP Lake Success New York United States 11042
    606 North Shore University Hospital Manhasset New York United States 11030
    607 Orange Regional Medical Center Middletown New York United States 10940
    608 Northern Westchester Hospital Mount Kisco New York United States 10549
    609 Long Island Jewish Medical Center New Hyde Park New York United States 11040
    610 Mount Sinai Union Square New York New York United States 10003
    611 Laura and Isaac Perlmutter Cancer Center at NYU Langone New York New York United States 10016
    612 Mount Sinai West New York New York United States 10019
    613 NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York New York United States 10032
    614 NYP/Weill Cornell Medical Center New York New York United States 10065
    615 Nyack Hospital Nyack New York United States 10960
    616 Champlain Valley Physicians Hospital Medical Center Plattsburgh New York United States 12901
    617 New York Oncology Hematology PC - Rexford Rexford New York United States 12148
    618 Interlakes Foundation Inc-Rochester Rochester New York United States 14623
    619 University of Rochester Rochester New York United States 14642
    620 Staten Island University Hospital Staten Island New York United States 10305
    621 State University of New York Upstate Medical University Syracuse New York United States 13210
    622 New York Oncology Hematology PC - Troy Troy New York United States 12180
    623 Faxton-Saint Luke's Healthcare Utica New York United States 13502
    624 Mission Hospital Inc-Memorial Campus Asheville North Carolina United States 28801
    625 Cone Health Cancer Center at Alamance Regional Burlington North Carolina United States 27215
    626 Waverly Hematology Oncology Cary North Carolina United States 27518
    627 Carolinas Medical Center/Levine Cancer Institute Charlotte North Carolina United States 28203
    628 Novant Health Presbyterian Medical Center Charlotte North Carolina United States 28204
    629 Atrium Health Cabarrus/LCI-Concord Concord North Carolina United States 28025
    630 CaroMont Regional Medical Center Gastonia North Carolina United States 28054
    631 Southeastern Medical Oncology Center-Goldsboro Goldsboro North Carolina United States 27534
    632 Wayne Memorial Hospital Goldsboro North Carolina United States 27534
    633 East Carolina University Greenville North Carolina United States 27834
    634 Margaret R Pardee Memorial Hospital Hendersonville North Carolina United States 28791
    635 High Point Regional Hospital High Point North Carolina United States 27262
    636 Vidant Oncology-Kinston Kinston North Carolina United States 28501
    637 FirstHealth of the Carolinas-Moore Regional Hospital Pinehurst North Carolina United States 28374
    638 Rex Cancer Center Raleigh North Carolina United States 27607
    639 Rutherford Hospital Rutherfordton North Carolina United States 28139
    640 Novant Health Forsyth Medical Center Winston-Salem North Carolina United States 27103
    641 Southeast Clinical Oncology Research (SCOR) Consortium NCORP Winston-Salem North Carolina United States 27104
    642 Mid Dakota Clinic Bismarck North Dakota United States 58501
    643 Saint Alexius Medical Center Bismarck North Dakota United States 58501
    644 Sanford Bismarck Medical Center Bismarck North Dakota United States 58501
    645 Essentia Health Cancer Center-South University Clinic Fargo North Dakota United States 58103
    646 Sanford Broadway Medical Center Fargo North Dakota United States 58122
    647 Sanford Clinic North-Fargo Fargo North Dakota United States 58122
    648 Trinity Cancer Care Center Minot North Dakota United States 58701
    649 Summa Akron City Hospital/Cooper Cancer Center Akron Ohio United States 44304
    650 Cleveland Clinic Akron General Akron Ohio United States 44307
    651 Summa Barberton Hospital Barberton Ohio United States 44203
    652 Cleveland Clinic Cancer Center Beachwood Beachwood Ohio United States 44122
    653 Mary Rutan Hospital Bellefontaine Ohio United States 43311
    654 Toledo Clinic Cancer Centers-Bowling Green Bowling Green Ohio United States 43402
    655 Mercy Medical Center Canton Ohio United States 44708
    656 Aultman Health Foundation Canton Ohio United States 44710
    657 Adena Regional Medical Center Chillicothe Ohio United States 45601
    658 The Christ Hospital Cincinnati Ohio United States 45219
    659 University of Cincinnati/Barrett Cancer Center Cincinnati Ohio United States 45219
    660 Oncology Hematology Care Inc-Blue Ash Cincinnati Ohio United States 45242
    661 Case Western Reserve University Cleveland Ohio United States 44106
    662 MetroHealth Medical Center Cleveland Ohio United States 44109
    663 Cleveland Clinic Cancer Center/Fairview Hospital Cleveland Ohio United States 44111
    664 Cleveland Clinic Foundation Cleveland Ohio United States 44195
    665 North Coast Cancer Care-Clyde Clyde Ohio United States 43410
    666 Ohio State University Comprehensive Cancer Center Columbus Ohio United States 43210
    667 Riverside Methodist Hospital Columbus Ohio United States 43214
    668 Columbus NCI Community Oncology Research Program Columbus Ohio United States 43215
    669 Grant Medical Center Columbus Ohio United States 43215
    670 Mount Carmel Health Center West Columbus Ohio United States 43222
    671 Doctors Hospital Columbus Ohio United States 43228
    672 Grandview Hospital Dayton Ohio United States 45405
    673 Good Samaritan Hospital - Dayton Dayton Ohio United States 45406
    674 Miami Valley Hospital Dayton Ohio United States 45409
    675 Miami Valley Hospital North Dayton Ohio United States 45415
    676 Dayton NCI Community Oncology Research Program Dayton Ohio United States 45420
    677 Veteran Affairs Medical Center Dayton Ohio United States 45428
    678 Grady Memorial Hospital Delaware Ohio United States 43015
    679 Hematology Oncology Center Incorporated Elyria Ohio United States 44035
    680 Mercy Cancer Center-Elyria Elyria Ohio United States 44035
    681 Blanchard Valley Hospital Findlay Ohio United States 45840
    682 Atrium Medical Center-Middletown Regional Hospital Franklin Ohio United States 45005-1066
    683 Fremont Memorial Hospital Fremont Ohio United States 43420
    684 Wayne Hospital Greenville Ohio United States 45331
    685 Cleveland Clinic Cancer Center Independence Independence Ohio United States 44131
    686 Kettering Medical Center Kettering Ohio United States 45429
    687 Fairfield Medical Center Lancaster Ohio United States 43130
    688 Saint Rita's Medical Center Lima Ohio United States 45801
    689 Lima Memorial Hospital Lima Ohio United States 45804
    690 OhioHealth Mansfield Hospital Mansfield Ohio United States 44903
    691 Marietta Memorial Hospital Marietta Ohio United States 45750
    692 Saint Luke's Hospital Maumee Ohio United States 43537
    693 Toledo Clinic Cancer Centers-Maumee Maumee Ohio United States 43537
    694 Toledo Radiation Oncology at Northwest Ohio Onocolgy Center Maumee Ohio United States 43537
    695 Hillcrest Hospital Cancer Center Mayfield Heights Ohio United States 44124
    696 Licking Memorial Hospital Newark Ohio United States 43055
    697 Fisher-Titus Medical Center Norwalk Ohio United States 44857
    698 Saint Charles Hospital Oregon Ohio United States 43616
    699 Toledo Clinic Cancer Centers-Oregon Oregon Ohio United States 43616
    700 Firelands Regional Medical Center Sandusky Ohio United States 44870
    701 North Coast Cancer Care Sandusky Ohio United States 44870
    702 Springfield Regional Medical Center Springfield Ohio United States 45505
    703 ProMedica Flower Hospital Sylvania Ohio United States 43560
    704 Mercy Hospital of Tiffin Tiffin Ohio United States 44883
    705 The Toledo Hospital/Toledo Children's Hospital Toledo Ohio United States 43606
    706 Saint Vincent Mercy Medical Center Toledo Ohio United States 43608
    707 University of Toledo Toledo Ohio United States 43614
    708 Toledo Community Hospital Oncology Program CCOP Toledo Ohio United States 43617
    709 Mercy Saint Anne Hospital Toledo Ohio United States 43623
    710 Toledo Clinic Cancer Centers-Toledo Toledo Ohio United States 43623
    711 Upper Valley Medical Center Troy Ohio United States 45373
    712 Fulton County Health Center Wauseon Ohio United States 43567
    713 Saint Ann's Hospital Westerville Ohio United States 43081
    714 Clinton Memorial Hospital Wilmington Ohio United States 45177
    715 Cleveland Clinic Wooster Family Health and Surgery Center Wooster Ohio United States 44691
    716 Greene Memorial Hospital Xenia Ohio United States 45385
    717 Genesis Healthcare System Cancer Care Center Zanesville Ohio United States 43701
    718 Cancer Centers of Southwest Oklahoma Research Lawton Oklahoma United States 73505
    719 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
    720 Cancer Care Associates Oklahoma City Oklahoma United States 73120
    721 Natalie Warren Bryant Cancer Center at Saint Francis Tulsa Oklahoma United States 74136
    722 Bend Memorial Clinic Bend Oregon United States 97701
    723 Saint Charles Health System Bend Oregon United States 97701
    724 Bay Area Hospital Coos Bay Oregon United States 97420
    725 Legacy Mount Hood Medical Center Gresham Oregon United States 97030
    726 Providence Milwaukie Hospital Milwaukie Oregon United States 97222
    727 Legacy Good Samaritan Hospital and Medical Center Portland Oregon United States 97210
    728 Providence Portland Medical Center Portland Oregon United States 97213
    729 Adventist Medical Center Portland Oregon United States 97216
    730 Providence Saint Vincent Medical Center Portland Oregon United States 97225
    731 Compass Oncology Rose Quarter Portland Oregon United States 97227
    732 Kaiser Permanente Northwest Portland Oregon United States 97227
    733 Legacy Emanuel Hospital and Health Center Portland Oregon United States 97227
    734 Oregon Health and Science University Portland Oregon United States 97239
    735 Salem Hospital Salem Oregon United States 97301
    736 Mid-Columbia Medical Center/Celilo Cancer Center The Dalles Oregon United States 97058
    737 Legacy Meridian Park Hospital Tualatin Oregon United States 97062
    738 Abington Memorial Hospital Abington Pennsylvania United States 19001
    739 Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania United States 18103
    740 Saint Luke's University Hospital-Bethlehem Campus Bethlehem Pennsylvania United States 18015
    741 Bryn Mawr Hospital Bryn Mawr Pennsylvania United States 19010
    742 Geisinger Medical Center Danville Pennsylvania United States 17822
    743 Doylestown Hospital Doylestown Pennsylvania United States 18901
    744 Oncology Hematology Associates of Northern Pennsylvania DuBois Pennsylvania United States 15801
    745 Pocono Medical Center East Stroudsburg Pennsylvania United States 18301
    746 Ephrata Cancer Center Ephrata Pennsylvania United States 17522
    747 Adams Cancer Center Gettysburg Pennsylvania United States 17325
    748 UPMC Pinnacle Cancer Center/Community Osteopathic Campus Harrisburg Pennsylvania United States 17109
    749 Geisinger Medical Center-Cancer Center Hazleton Hazleton Pennsylvania United States 18201
    750 Penn State Milton S Hershey Medical Center Hershey Pennsylvania United States 17033-0850
    751 Armstrong Center for Medicine and Health Kittanning Pennsylvania United States 16201
    752 Lancaster General Hospital Lancaster Pennsylvania United States 17604
    753 Central PA Hematology-Medical Oncology Associates PC Lemoyne Pennsylvania United States 17043
    754 Lewistown Hospital Lewistown Pennsylvania United States 17044
    755 Riddle Memorial Hospital Media Pennsylvania United States 19063
    756 Paoli Memorial Hospital Paoli Pennsylvania United States 19301
    757 University of Pennsylvania/Abramson Cancer Center Philadelphia Pennsylvania United States 19104
    758 Pennsylvania Hospital Philadelphia Pennsylvania United States 19107
    759 Thomas Jefferson University Hospital Philadelphia Pennsylvania United States 19107
    760 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111
    761 Aria Health-Torresdale Campus Philadelphia Pennsylvania United States 19114
    762 Einstein Medical Center Philadelphia Philadelphia Pennsylvania United States 19141
    763 Allegheny General Hospital Pittsburgh Pennsylvania United States 15212
    764 University of Pittsburgh Cancer Institute (UPCI) Pittsburgh Pennsylvania United States 15232
    765 Pottstown Hospital Pottstown Pennsylvania United States 19464
    766 Penn State Health Saint Joseph Medical Center Reading Pennsylvania United States 19605
    767 Guthrie Medical Group PC-Robert Packer Hospital Sayre Pennsylvania United States 18840
    768 Mercy Hospital Scranton Pennsylvania United States 18501
    769 Hematology and Oncology Associates of North East Pennsylvania Scranton Pennsylvania United States 18508
    770 Scranton Hematology Oncology Scranton Pennsylvania United States 18510
    771 Grand View Hospital Sellersville Pennsylvania United States 18960
    772 Geisinger Medical Group State College Pennsylvania United States 16801
    773 Mount Nittany Medical Center State College Pennsylvania United States 16803
    774 Associates In Hematology Oncology PC-Upland Upland Pennsylvania United States 19013
    775 Chester County Hospital West Chester Pennsylvania United States 19380
    776 Reading Hospital West Reading Pennsylvania United States 19611
    777 Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre Pennsylvania United States 18711
    778 UPMC Susquehanna Williamsport Pennsylvania United States 17701
    779 Lankenau Medical Center Wynnewood Pennsylvania United States 19096
    780 Main Line Health NCORP Wynnewood Pennsylvania United States 19096
    781 WellSpan Health-York Hospital York Pennsylvania United States 17403
    782 Hematology and Oncology Associates of Rhode Island Inc Cranston Rhode Island United States 02920
    783 Memorial Hospital of Rhode Island Pawtucket Rhode Island United States 02860
    784 Rhode Island Hospital Providence Rhode Island United States 02903
    785 Miriam Hospital Providence Rhode Island United States 02906
    786 Kent Hospital Warwick Rhode Island United States 02886
    787 AnMed Health Hospital Anderson South Carolina United States 29621
    788 Roper Hospital Charleston South Carolina United States 29401
    789 Medical University of South Carolina Charleston South Carolina United States 29425
    790 Greenville Health System Cancer Institute-Easley Easley South Carolina United States 29640
    791 McLeod Regional Medical Center Florence South Carolina United States 29506
    792 Greenville Health System Cancer Institute-Andrews Greenville South Carolina United States 29601
    793 Saint Francis Hospital Greenville South Carolina United States 29601
    794 Greenville Health System Cancer Institute-Butternut Greenville South Carolina United States 29605
    795 Greenville Health System Cancer Institute-Faris Greenville South Carolina United States 29605
    796 Greenville Memorial Hospital Greenville South Carolina United States 29605
    797 Greenville Health System Cancer Institute-Eastside Greenville South Carolina United States 29615
    798 Self Regional Healthcare Greenwood South Carolina United States 29646
    799 Greenville Health System Cancer Institute-Greer Greer South Carolina United States 29650
    800 Greenville Health System Cancer Institute-Seneca Seneca South Carolina United States 29672
    801 Spartanburg Medical Center Spartanburg South Carolina United States 29303
    802 Greenville Health System Cancer Institute-Spartanburg Spartanburg South Carolina United States 29307
    803 Avera Cancer Institute-Aberdeen Aberdeen South Dakota United States 57401
    804 Rapid City Regional Hospital Rapid City South Dakota United States 57701
    805 Sanford Cancer Center Oncology Clinic Sioux Falls South Dakota United States 57104
    806 Avera Cancer Institute Sioux Falls South Dakota United States 57105
    807 Avera McKennan Hospital and University Health Center Sioux Falls South Dakota United States 57105
    808 Medical X-Ray Center Sioux Falls South Dakota United States 57105
    809 Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota United States 57117-5134
    810 Erlanger Medical Center Chattanooga Tennessee United States 37403
    811 Vanderbilt-Ingram Cancer Center Cool Springs Franklin Tennessee United States 37067
    812 Jones Clinic Germantown Tennessee United States 38138
    813 Jackson-Madison County General Hospital Jackson Tennessee United States 38301
    814 Wellmont Holston Valley Hospital and Medical Center Kingsport Tennessee United States 37660
    815 Thompson Cancer Survival Center Knoxville Tennessee United States 37916
    816 East Tennessee Baptist Hospital-Mercy Health Partners Knoxville Tennessee United States 37920
    817 University of Tennessee - Knoxville Knoxville Tennessee United States 37920
    818 University of Tennessee Health Science Center Memphis Tennessee United States 38163
    819 Nashville Oncology Associates PC Nashville Tennessee United States 37203
    820 Meharry Medical College Nashville Tennessee United States 37208
    821 Vanderbilt University/Ingram Cancer Center Nashville Tennessee United States 37232
    822 The Don and Sybil Harrington Cancer Center Amarillo Texas United States 79106
    823 Texas Oncology-Austin Midtown Austin Texas United States 78705
    824 Texas Oncology - Central Austin Cancer Center Austin Texas United States 78731
    825 Texas Oncology - South Austin Cancer Center Austin Texas United States 78745
    826 Texas Oncology-Austin North Austin Texas United States 78758
    827 Texas Oncology Seton Northwest Austin Texas United States 78759
    828 Medical City Dallas Hospital Dallas Texas United States 75230
    829 Texas Health Presbyterian Hospital Dallas Dallas Texas United States 75231
    830 Parkland Memorial Hospital Dallas Texas United States 75235
    831 Clements University Hospital Dallas Texas United States 75390
    832 UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas United States 75390
    833 Dallas Oncology Consultants PA Duncanville Texas United States 75137
    834 The Center for Integrative Cancer Medicine El Paso Texas United States 79902
    835 Brooke Army Medical Center Fort Sam Houston Texas United States 78234
    836 Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston Texas United States 77030
    837 Baylor Saint Luke's Medical Center Houston Texas United States 77030
    838 Ben Taub General Hospital Houston Texas United States 77030
    839 M D Anderson Cancer Center Houston Texas United States 77030
    840 Michael E DeBakey VA Medical Center Houston Texas United States 77030
    841 The Methodist Hospital System Houston Texas United States 77030
    842 Wilford Hall Medical Center Lackland Air Force Base Texas United States 78236
    843 Texas Tech University Health Sciences Center-Lubbock Lubbock Texas United States 79430
    844 Texas Oncology-Seton Williamson Round Rock Texas United States 78665
    845 Texas Oncology - Round Rock Cancer Center Round Rock Texas United States 78681
    846 Audie L Murphy VA Hospital San Antonio Texas United States 78229
    847 Cancer Therapy and Research Center at The UT Health Science Center at San Antonio San Antonio Texas United States 78229
    848 University Hospital San Antonio Texas United States 78229
    849 University of Texas Health Science Center at San Antonio San Antonio Texas United States 78229
    850 Texas Oncology- San Marcos San Marcos Texas United States 78666
    851 Scott and White Memorial Hospital Temple Texas United States 76508
    852 American Fork Hospital / Huntsman Intermountain Cancer Center American Fork Utah United States 84003
    853 Sandra L Maxwell Cancer Center Cedar City Utah United States 84720
    854 Logan Regional Hospital Logan Utah United States 84321
    855 Cottonwood Hospital Medical Center Murray Utah United States 84107
    856 Intermountain Medical Center Murray Utah United States 84107
    857 McKay-Dee Hospital Center Ogden Utah United States 84403
    858 Utah Valley Regional Medical Center Provo Utah United States 84604
    859 Dixie Medical Center Regional Cancer Center Saint George Utah United States 84770
    860 Intermountain Health Care Salt Lake City Utah United States 84103
    861 Utah Cancer Specialists-Salt Lake City Salt Lake City Utah United States 84106
    862 Huntsman Cancer Institute/University of Utah Salt Lake City Utah United States 84112
    863 LDS Hospital Salt Lake City Utah United States 84143
    864 Southwestern Vermont Medical Center Bennington Vermont United States 05201
    865 Central Vermont Medical Center/National Life Cancer Treatment Berlin Vermont United States 05602
    866 University of Vermont and State Agricultural College Burlington Vermont United States 05405
    867 University of Virginia Cancer Center Charlottesville Virginia United States 22908
    868 Danville Regional Medical Center Danville Virginia United States 24541
    869 Fredericksburg Oncology Inc Fredericksburg Virginia United States 22401
    870 Peninsula Cancer Institute-Gloucester Gloucester Virginia United States 23061
    871 Centra Lynchburg Hematology-Oncology Clinic Inc Lynchburg Virginia United States 24501
    872 Peninsula Cancer Institute-Newport News Newport News Virginia United States 23601
    873 Southwest VA Regional Cancer Center Norton Virginia United States 24273
    874 Virginia Commonwealth University/Massey Cancer Center Richmond Virginia United States 23298
    875 Peninsula Cancer Institute-Williamsburg Williamsburg Virginia United States 23185
    876 MultiCare Auburn Medical Center Auburn Washington United States 98001
    877 PeaceHealth Saint Joseph Medical Center Bellingham Washington United States 98225
    878 Harrison HealthPartners Hematology and Oncology-Bremerton Bremerton Washington United States 98310
    879 Providence Regional Cancer System-Centralia Centralia Washington United States 98531
    880 Saint Francis Hospital Federal Way Washington United States 98003
    881 Kadlec Clinic Hematology and Oncology Kennewick Washington United States 99336
    882 EvergreenHealth Medical Center Kirkland Washington United States 98033
    883 Saint Clare Hospital Lakewood Washington United States 98499
    884 Skagit Valley Hospital Mount Vernon Washington United States 98274
    885 Providence - Saint Peter Hospital Olympia Washington United States 98506-5166
    886 Olympic Medical Center Port Angeles Washington United States 98362
    887 Harrison HealthPartners Hematology and Oncology-Poulsbo Poulsbo Washington United States 98370
    888 MultiCare Good Samaritan Hospital Puyallup Washington United States 98372
    889 Valley Medical Center Renton Washington United States 98055
    890 Virginia Mason Medical Center Seattle Washington United States 98101
    891 Minor and James Medical PLLC Seattle Washington United States 98104
    892 Pacific Medical Center-First Hill Seattle Washington United States 98104
    893 Kaiser Permanente Washington Seattle Washington United States 98112
    894 Swedish Medical Center-First Hill Seattle Washington United States 98122-4307
    895 University of Washington Medical Center Seattle Washington United States 98195
    896 Cancer Care Northwest - Spokane South Spokane Washington United States 99202
    897 Providence Sacred Heart Medical Center and Children's Hospital Spokane Washington United States 99204
    898 Providence Holy Family Hospital Spokane Washington United States 99208
    899 Rockwood Clinic Spokane Washington United States 99220
    900 MultiCare Allenmore Hospital Tacoma Washington United States 98405
    901 MultiCare Tacoma General Hospital Tacoma Washington United States 98405
    902 Northwest NCI Community Oncology Research Program Tacoma Washington United States 98405
    903 Saint Joseph Medical Center Tacoma Washington United States 98405
    904 Madigan Army Medical Center Tacoma Washington United States 98431
    905 PeaceHealth Southwest Medical Center Vancouver Washington United States 98664
    906 Compass Oncology Vancouver Vancouver Washington United States 98684
    907 Legacy Salmon Creek Hospital Vancouver Washington United States 98686
    908 Wenatchee Valley Hospital and Clinics Wenatchee Washington United States 98801
    909 Cancer Institutes of Washington PLLC Yakima Washington United States 98902
    910 North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima Washington United States 98902
    911 West Virginia University Charleston Division Charleston West Virginia United States 25304
    912 Edwards Comprehensive Cancer Center Huntington West Virginia United States 25701
    913 Saint Mary's Medical Center Huntington West Virginia United States 25702
    914 West Virginia University Healthcare Morgantown West Virginia United States 26506
    915 Camden Clark Medical Center Parkersburg West Virginia United States 26101
    916 Wheeling Hospital/Schiffler Cancer Center Wheeling West Virginia United States 26003
    917 Langlade Hospital and Cancer Center Antigo Wisconsin United States 54409
    918 Fox Valley Hematology and Oncology SC-Appleton Appleton Wisconsin United States 54913
    919 Aurora Cancer Care-Southern Lakes VLCC Burlington Wisconsin United States 53105
    920 Marshfield Clinic-Chippewa Center Chippewa Falls Wisconsin United States 54729
    921 HSHS Sacred Heart Hospital Eau Claire Wisconsin United States 54701
    922 Marshfield Clinic Cancer Center at Sacred Heart Eau Claire Wisconsin United States 54701
    923 Aurora Cancer Care-Franklin Franklin Wisconsin United States 53132
    924 Aurora Health Care Germantown Health Center Germantown Wisconsin United States 53022
    925 Aurora Cancer Care-Glendale Glendale Wisconsin United States 53212
    926 Green Bay Oncology at Saint Vincent Hospital Green Bay Wisconsin United States 54301-3526
    927 Saint Vincent Hospital Cancer Center Green Bay Green Bay Wisconsin United States 54301
    928 Green Bay Oncology Limited at Saint Mary's Hospital Green Bay Wisconsin United States 54303
    929 Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay Wisconsin United States 54303
    930 Aurora BayCare Medical Center Green Bay Wisconsin United States 54311
    931 UW Cancer Center Johnson Creek Johnson Creek Wisconsin United States 53038
    932 Aurora Cancer Care-Kenosha South Kenosha Wisconsin United States 53142
    933 Gundersen Lutheran Medical Center La Crosse Wisconsin United States 54601
    934 Mayo Clinic Health System-Franciscan Healthcare La Crosse Wisconsin United States 54601
    935 UW Health Oncology-One South Park Madison Wisconsin United States 53715
    936 Dean Hematology and Oncology Clinic Madison Wisconsin United States 53717
    937 University of Wisconsin Hospital and Clinics Madison Wisconsin United States 53792
    938 Holy Family Memorial Hospital Manitowoc Wisconsin United States 54221
    939 Aurora Bay Area Medical Group-Marinette Marinette Wisconsin United States 54143
    940 Bay Area Medical Center Marinette Wisconsin United States 54143
    941 Marshfield Medical Center-Marshfield Marshfield Wisconsin United States 54449
    942 Marshfield Medical Center Marshfield Wisconsin United States 54449
    943 Aurora Saint Luke's Medical Center Milwaukee Wisconsin United States 53215
    944 Froedtert and the Medical College of Wisconsin Milwaukee Wisconsin United States 53226
    945 Aurora Sinai Medical Center Milwaukee Wisconsin United States 53233
    946 Marshfield Clinic-Minocqua Center Minocqua Wisconsin United States 54548
    947 Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls Wisconsin United States 54154
    948 Vince Lombardi Cancer Clinic - Oshkosh Oshkosh Wisconsin United States 54904
    949 Aurora Cancer Care-Racine Racine Wisconsin United States 53406
    950 Ascension Saint Mary's Hospital Rhinelander Wisconsin United States 54501
    951 Marshfield Medical Center-Rice Lake Rice Lake Wisconsin United States 54868
    952 Vince Lombardi Cancer Clinic-Sheboygan Sheboygan Wisconsin United States 53081
    953 Ascension Saint Michael's Hospital Stevens Point Wisconsin United States 54481
    954 Saint Michael's Hospital Stevens Point Wisconsin United States 54481
    955 Green Bay Oncology - Sturgeon Bay Sturgeon Bay Wisconsin United States 54235
    956 Aurora Medical Center in Summit Summit Wisconsin United States 53066
    957 Vince Lombardi Cancer Clinic-Two Rivers Two Rivers Wisconsin United States 54241
    958 Aurora Cancer Care-Waukesha Waukesha Wisconsin United States 53188
    959 Aspirus Regional Cancer Center Wausau Wisconsin United States 54401
    960 Marshfield Clinic-Wausau Center Wausau Wisconsin United States 54401
    961 Aurora Cancer Care-Milwaukee West Wauwatosa Wisconsin United States 53226
    962 Marshfield Clinic - Weston Center Weston Wisconsin United States 54476
    963 Aspirus UW Cancer Center Wisconsin Rapids Wisconsin United States 54494
    964 Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids Wisconsin United States 54494
    965 Rocky Mountain Oncology Casper Wyoming United States 82609
    966 Welch Cancer Center Sheridan Wyoming United States 82801
    967 Tom Baker Cancer Centre Calgary Alberta Canada T2N 4N2
    968 Cross Cancer Institute Edmonton Alberta Canada T6G 1Z2
    969 Clinical Research Unit at Vancouver Coastal Health Authority Vancouver British Columbia Canada V5Z 3P1
    970 CancerCare Manitoba Winnipeg Manitoba Canada R3E 0V9
    971 The Moncton Hospital Moncton New Brunswick Canada E1C 6Z8
    972 Atlantic Health Sciences Corporation-Saint John Regional Hospital Saint John New Brunswick Canada E2L 4L2
    973 QEII Health Sciences Centre/Nova Scotia Health Authority Halifax Nova Scotia Canada B3H 2Y9
    974 Juravinski Cancer Centre at Hamilton Health Sciences Hamilton Ontario Canada L8V 5C2
    975 Grand River Regional Cancer Centre at Grand River Hospital Kitchener Ontario Canada N2G 1G3
    976 London Regional Cancer Program London Ontario Canada N6A 4L6
    977 Lakeridge Health Oshawa Oshawa Ontario Canada L1G 2B9
    978 Ottawa Hospital and Cancer Center-General Campus Ottawa Ontario Canada K1H 8L6
    979 Algoma District Cancer Program Sault Area Hospital Sault Ste Marie Ontario Canada P6B 0A8
    980 Thunder Bay Regional Health Science Centre Thunder Bay Ontario Canada P7B 6V4
    981 Odette Cancer Centre- Sunnybrook Health Sciences Centre Toronto Ontario Canada M4N 3M5
    982 University Health Network-Princess Margaret Hospital Toronto Ontario Canada M5G 2M9
    983 PEI Cancer Treatment Centre-Queen Elizabeth Hospital Charlottetown Prince Edward Island Canada C1A 8T5
    984 CHUM - Hopital Notre-Dame Montreal Quebec Canada H2L 4M1
    985 McGill University Department of Oncology Montreal Quebec Canada H2W 1S6
    986 CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ) Quebec City Quebec Canada G1R 2J6
    987 San Juan City Hospital San Juan Puerto Rico 00936

    Sponsors and Collaborators

    • National Cancer Institute (NCI)
    • Cancer and Leukemia Group B
    • NCIC Clinical Trials Group
    • Southwest Oncology Group

    Investigators

    • Principal Investigator: Naomi S Balzer-Haas, ECOG-ACRIN Cancer Research Group

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT00326898
    Other Study ID Numbers:
    • NCI-2009-00534
    • NCI-2009-00534
    • CAN-NCIC-E2805
    • SWOG-E2805
    • ECOG-E2805
    • CDR0000478976
    • CALGB-E2805
    • E2805
    • E2805
    • U10CA180820
    • U10CA021115
    First Posted:
    May 17, 2006
    Last Update Posted:
    Feb 8, 2022
    Last Verified:
    Jan 1, 2022
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details The study was activated on April 24, 2006 and closed to accrual on September 1, 2010, after accrual of 1943 patients.
    Pre-assignment Detail
    Arm/Group Title Arm A (Sunitinib + Sorafenib Placebo) Arm B (Sorafenib + Sunitinib Placebo) Arm C (Sunitinib Placebo + Sorafenib Placebo)
    Arm/Group Description Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate 37.5mg PO QD for 4 weeks and placebo sorafenib tosylate 400mg PO QD or BID for 6 weeks. Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate 400mg PO QD or BID for 6 weeks and placebo sunitinib malate 37.5mg PO QD for 4 weeks followed. Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate 400mg as in Arm A and placebo sunitinib malate 37.5mg as in Arm B.
    Period Title: Overall Study
    STARTED 647 649 647
    Patients With Toxicity Data 625 628 626
    Patients With Clear Cell Histology 542 540 540
    Patients With >=1 Follow-up MUGA Scan 513 510 580
    COMPLETED 296 306 444
    NOT COMPLETED 351 343 203

    Baseline Characteristics

    Arm/Group Title Arm A (Sunitinib + Sorafenib Placebo) Arm B (Sorafenib + Sunitinib Placebo) Arm C (Sunitinib Placebo + Sorafenib Placebo) Total
    Arm/Group Description Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate 37.5mg PO QD for 4 weeks and placebo sorafenib tosylate 400mg PO QD or BID for 6 weeks. Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate 400mg PO QD or BID for 6 weeks and placebo sunitinib malate 37.5mg PO QD for 4 weeks followed. Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate 400mg as in Arm A and placebo sunitinib malate 37.5mg as in Arm B. Total of all reporting groups
    Overall Participants 647 649 647 1943
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    489
    75.6%
    507
    78.1%
    500
    77.3%
    1496
    77%
    >=65 years
    158
    24.4%
    142
    21.9%
    147
    22.7%
    447
    23%
    Sex: Female, Male (Count of Participants)
    Female
    218
    33.7%
    212
    32.7%
    204
    31.5%
    634
    32.6%
    Male
    429
    66.3%
    437
    67.3%
    443
    68.5%
    1309
    67.4%

    Outcome Measures

    1. Primary Outcome
    Title Disease-free Survival (DFS)
    Description Disease-free survival (DFS) is defined as time from randomization to recurrence, development of second primary cancer (except localized breast or prostate cancer or nonmelanoma skin cancer), or death from any cause. Patients who were alive without recurrence or qualifying second primary cancer were censored at the date of last disease evaluation.
    Time Frame Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry

    Outcome Measure Data

    Analysis Population Description
    All randomized patients
    Arm/Group Title Arm A (Sunitinib + Sorafenib Placebo) Arm B (Sorafenib + Sunitinib Placebo) Arm C (Sunitinib Placebo + Sorafenib Placebo)
    Arm/Group Description Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate 37.5mg PO QD for 4 weeks and placebo sorafenib tosylate 400mg PO QD or BID for 6 weeks. Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate 400mg PO QD or BID for 6 weeks and placebo sunitinib malate 37.5mg PO QD for 4 weeks followed. Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate 400mg as in Arm A and placebo sunitinib malate 37.5mg as in Arm B.
    Measure Participants 647 649 647
    Median (97.5% Confidence Interval) [years]
    5.8
    6.1
    6.6
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Arm A (Sunitinib + Sorafenib Placebo), Arm C (Sunitinib Placebo + Sorafenib Placebo)
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.80
    Comments
    Method Stratified logrank test
    Comments Stratified logrank test was performed. Stratification factors include basis of risk group, histologic subtype, performance status and type of surgery.
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 1.02
    Confidence Interval (2-Sided) 97.5%
    0.85 to 1.23
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Arm B (Sorafenib + Sunitinib Placebo), Arm C (Sunitinib Placebo + Sorafenib Placebo)
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.72
    Comments
    Method Stratified logrank test
    Comments Stratified logrank test was performed. Stratification factors include basis of risk group, histologic subtype, performance status and type of surgery.
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.97
    Confidence Interval (2-Sided) 97.5%
    0.80 to 1.17
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Secondary Outcome
    Title 5-year Overall Survival Rate
    Description Overall survival is defined as the time from randomization to death from any cause. Patients without a date of death were censored at the date of last contact. Kaplan-Meier method was used to estimate 5-year survival rate.
    Time Frame Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry

    Outcome Measure Data

    Analysis Population Description
    All randomized patients
    Arm/Group Title Arm A (Sunitinib + Sorafenib Placebo) Arm B (Sorafenib + Sunitinib Placebo) Arm C (Sunitinib Placebo + Sorafenib Placebo)
    Arm/Group Description Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate 37.5mg PO QD for 4 weeks and placebo sorafenib tosylate 400mg PO QD or BID for 6 weeks. Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate 400mg PO QD or BID for 6 weeks and placebo sunitinib malate 37.5mg PO QD for 4 weeks followed. Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate 400mg as in Arm A and placebo sunitinib malate 37.5mg as in Arm B.
    Measure Participants 647 649 647
    Number (97.5% Confidence Interval) [proportion of participants]
    0.779
    0.1%
    0.805
    0.1%
    0.803
    0.1%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Arm A (Sunitinib + Sorafenib Placebo), Arm C (Sunitinib Placebo + Sorafenib Placebo)
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 1.17
    Confidence Interval (2-Sided) 97.5%
    0.90 to 1.52
    Parameter Dispersion Type:
    Value:
    Estimation Comments Hazard ratio was estimated using stratified proportional hazards model with Arm C (placebo arm) as the reference group.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Arm B (Sorafenib + Sunitinib Placebo), Arm C (Sunitinib Placebo + Sorafenib Placebo)
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.98
    Confidence Interval (2-Sided) 97.5%
    0.75 to 1.28
    Parameter Dispersion Type:
    Value:
    Estimation Comments Hazard ratio was estimated using stratified proportional hazards model with Arm C (placebo arm) as the reference group.
    3. Secondary Outcome
    Title Proportion of Patients With Cardiac Events
    Description Cardiac event is defined as left ventricular ejection fraction (LVEF) below the institutional lower limit of normal, where the decrease was >15% absolute percentage points from baseline within 6 months.
    Time Frame Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry

    Outcome Measure Data

    Analysis Population Description
    Patients with at least 1 follow-up MUGA scan were included in this analysis.
    Arm/Group Title Arm A (Sunitinib + Sorafenib Placebo) Arm B (Sorafenib + Sunitinib Placebo) Arm C (Sunitinib Placebo + Sorafenib Placebo)
    Arm/Group Description Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate 37.5mg PO QD for 4 weeks and placebo sorafenib tosylate 400mg PO QD or BID for 6 weeks. Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate 400mg PO QD or BID for 6 weeks and placebo sunitinib malate 37.5mg PO QD for 4 weeks followed. Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate 400mg as in Arm A and placebo sunitinib malate 37.5mg as in Arm B.
    Measure Participants 513 510 580
    Number (90% Confidence Interval) [Proportion of participants]
    0.017
    0%
    0.013
    0%
    0.008
    0%
    4. Secondary Outcome
    Title 5-year Disease-free Survival (DFS) Rate Among Patients With Clear Cell Histology
    Description Disease-free survival (DFS) is defined as time from randomization to recurrence, development of second primary cancer (except localized breast or prostate cancer or nonmelanoma skin cancer), or death from any cause. Patients who were alive without recurrence or qualifying second primary cancer were censored at the date of last disease evaluation. 5-year DFS rate is the proportion of patients who are alive and disease-free at 5 years based on the Kaplan-Meier estimate.
    Time Frame Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry

    Outcome Measure Data

    Analysis Population Description
    Patients with clear cell histology were included in this analysis.
    Arm/Group Title Arm A (Sunitinib + Sorafenib Placebo) Arm B (Sorafenib + Sunitinib Placebo) Arm C (Sunitinib Placebo + Sorafenib Placebo)
    Arm/Group Description Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate 37.5mg PO QD for 4 weeks and placebo sorafenib tosylate 400mg PO QD or BID for 6 weeks. Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate 400mg PO QD or BID for 6 weeks and placebo sunitinib malate 37.5mg PO QD for 4 weeks followed. Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate 400mg as in Arm A and placebo sunitinib malate 37.5mg as in Arm B.
    Measure Participants 542 540 540
    Number (97.5% Confidence Interval) [proportion of participants]
    0.534
    0.1%
    0.527
    0.1%
    0.560
    0.1%
    5. Other Pre-specified Outcome
    Title The Association Between Angiogenesis Markers and Disease-free Survival
    Description
    Time Frame Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    6. Other Pre-specified Outcome
    Title The Association Between Disease-free Survival and the Frequency of Oncogene as Well as Tumor Suppressor Gene Mutations
    Description
    Time Frame Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    7. Other Pre-specified Outcome
    Title The Association Between Tumor and Genetic Polymorphisms and Disease-free Survival
    Description
    Time Frame Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    8. Other Pre-specified Outcome
    Title The Association Between Deoxyribonucleic Acid (DNA) Methylation Profiles and Disease-free Survival
    Description
    Time Frame Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    9. Other Pre-specified Outcome
    Title The Relationship of Polymorphisms in Drug Metabolizing Enzymes With Steady State Concentrations of Sorafenib and Sunitinib in Selected Patients
    Description
    Time Frame Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    10. Other Pre-specified Outcome
    Title The Effect of Vascular Endothelial Growth Factor (VEGF) Targeted Therapy on Circulating Endothelial Cells and Circulating Endothelial Progenitors
    Description
    Time Frame Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    11. Other Pre-specified Outcome
    Title Patient-reported Fatigue Using Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale
    Description
    Time Frame Assessed at baseline, 10 weeks and 22 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    12. Other Pre-specified Outcome
    Title Patient-reported Fatigue Using the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form
    Description PROMIS Fatigue short form is a newly developed state-of-the-science PROMIS measure for fatigue
    Time Frame Assessed at baseline, 10 weeks and 22 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    13. Other Pre-specified Outcome
    Title The Association Between Scan Frequency and Development of Congestive Heart Failure
    Description
    Time Frame Assessed at 3, 6 and 12 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    14. Other Pre-specified Outcome
    Title Frequency of Clinically Significant Congestive Heart Failure (CHF) Grade 3 or Higher Using the Common Terminology Criteria for Adverse Events Version 4.0
    Description
    Time Frame Assessed every 6 weeks while on treatment and for 30 days after the end of treatment

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description

    Adverse Events

    Time Frame Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
    Adverse Event Reporting Description Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
    Arm/Group Title Arm A (Sunitinib + Sorafenib Placebo) Arm B (Sorafenib + Sunitinib Placebo) Arm C (Sunitinib Placebo + Sorafenib Placebo)
    Arm/Group Description Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate 37.5mg PO QD for 4 weeks and placebo sorafenib tosylate 400mg PO QD or BID for 6 weeks. Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate 400mg PO QD or BID for 6 weeks and placebo sunitinib malate 37.5mg PO QD for 4 weeks followed. Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate 400mg as in Arm A and placebo sunitinib malate 37.5mg as in Arm B.
    All Cause Mortality
    Arm A (Sunitinib + Sorafenib Placebo) Arm B (Sorafenib + Sunitinib Placebo) Arm C (Sunitinib Placebo + Sorafenib Placebo)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Arm A (Sunitinib + Sorafenib Placebo) Arm B (Sorafenib + Sunitinib Placebo) Arm C (Sunitinib Placebo + Sorafenib Placebo)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 368/625 (58.9%) 424/628 (67.5%) 81/626 (12.9%)
    Blood and lymphatic system disorders
    Anemia 2/625 (0.3%) 1/628 (0.2%) 0/626 (0%)
    Thrombotic microangiopathy 1/625 (0.2%) 0/628 (0%) 0/626 (0%)
    Febrile neutropenia 2/625 (0.3%) 0/628 (0%) 0/626 (0%)
    Cardiac disorders
    Heart block abnormality NOS 0/625 (0%) 0/628 (0%) 1/626 (0.2%)
    Atrial fibrillation 1/625 (0.2%) 0/628 (0%) 2/626 (0.3%)
    Atrial flutter 0/625 (0%) 0/628 (0%) 2/626 (0.3%)
    Sinus bradycardia 1/625 (0.2%) 0/628 (0%) 0/626 (0%)
    Supraventricular tachycardia 1/625 (0.2%) 0/628 (0%) 0/626 (0%)
    Bigeminy 1/625 (0.2%) 0/628 (0%) 0/626 (0%)
    Cardiac-ischemia 1/625 (0.2%) 3/628 (0.5%) 4/626 (0.6%)
    Left ventricular systolic dysfunction 4/625 (0.6%) 4/628 (0.6%) 2/626 (0.3%)
    Cor Pulmonale 0/625 (0%) 1/628 (0.2%) 0/626 (0%)
    cardiac-other 0/625 (0%) 1/628 (0.2%) 0/626 (0%)
    Cardiac/heart, pain 2/625 (0.3%) 3/628 (0.5%) 0/626 (0%)
    Ear and labyrinth disorders
    Hearing w/o audiogr not in monitor prg 1/625 (0.2%) 0/628 (0%) 0/626 (0%)
    Endocrine disorders
    Adrenal insufficiency 0/625 (0%) 1/628 (0.2%) 0/626 (0%)
    Hyopthyroidism 2/625 (0.3%) 0/628 (0%) 0/626 (0%)
    Eye disorders
    Cataract 0/625 (0%) 0/628 (0%) 1/626 (0.2%)
    Double vision 0/625 (0%) 0/628 (0%) 1/626 (0.2%)
    Retinal detachment 1/625 (0.2%) 0/628 (0%) 0/626 (0%)
    Ocular-other 0/625 (0%) 1/628 (0.2%) 0/626 (0%)
    Gastrointestinal disorders
    Colitis 0/625 (0%) 3/628 (0.5%) 0/626 (0%)
    Constipation 1/625 (0.2%) 0/628 (0%) 0/626 (0%)
    Diarrhea w/o prior colostomy 57/625 (9.1%) 55/628 (8.8%) 2/626 (0.3%)
    Distention/bloating, abdominal 0/625 (0%) 1/628 (0.2%) 0/626 (0%)
    Esophagitis 0/625 (0%) 1/628 (0.2%) 0/626 (0%)
    Gastritis 1/625 (0.2%) 1/628 (0.2%) 0/626 (0%)
    Dyspepsia 14/625 (2.2%) 4/628 (0.6%) 1/626 (0.2%)
    Ileus 0/625 (0%) 0/628 (0%) 1/626 (0.2%)
    Muco/stomatitis by exam, oral cavity 2/625 (0.3%) 0/628 (0%) 0/626 (0%)
    Muco/stomatitis (symptom) oral cavity 3/625 (0.5%) 1/628 (0.2%) 0/626 (0%)
    Nausea 22/625 (3.5%) 5/628 (0.8%) 0/626 (0%)
    Perforation, colon 0/625 (0%) 1/628 (0.2%) 0/626 (0%)
    Vomiting 11/625 (1.8%) 3/628 (0.5%) 1/626 (0.2%)
    Colon, hemorrhage 2/625 (0.3%) 0/628 (0%) 0/626 (0%)
    Lower GI, hemorrhage NOS 0/625 (0%) 1/628 (0.2%) 0/626 (0%)
    Stomach, hemorrhage 1/625 (0.2%) 0/628 (0%) 0/626 (0%)
    Pancreatitis 3/625 (0.5%) 1/628 (0.2%) 0/626 (0%)
    Abdomen, pain 4/625 (0.6%) 8/628 (1.3%) 2/626 (0.3%)
    Esophagus, pain 1/625 (0.2%) 0/628 (0%) 0/626 (0%)
    Oral cavity, pain 1/625 (0.2%) 1/628 (0.2%) 0/626 (0%)
    Stomach, pain 0/625 (0%) 1/628 (0.2%) 0/626 (0%)
    General disorders
    Fatigue 108/625 (17.3%) 41/628 (6.5%) 15/626 (2.4%)
    Fever w/o neutropenia 1/625 (0.2%) 2/628 (0.3%) 0/626 (0%)
    Edema head and neck 3/625 (0.5%) 1/628 (0.2%) 0/626 (0%)
    Edema limb 2/625 (0.3%) 0/628 (0%) 0/626 (0%)
    Chest/thoracic pain NOS 4/625 (0.6%) 4/628 (0.6%) 0/626 (0%)
    Pain-other 0/625 (0%) 1/628 (0.2%) 0/626 (0%)
    Flu-like syndrome 3/625 (0.5%) 0/628 (0%) 0/626 (0%)
    Hepatobiliary disorders
    Cholecystitis 1/625 (0.2%) 0/628 (0%) 0/626 (0%)
    Liver dysfunction/failure 1/625 (0.2%) 0/628 (0%) 0/626 (0%)
    Hepatic-other 1/625 (0.2%) 0/628 (0%) 0/626 (0%)
    Immune system disorders
    Allergic reaction 1/625 (0.2%) 0/628 (0%) 0/626 (0%)
    Infections and infestations
    Infection w/ gr3-4 neut, ileum 1/625 (0.2%) 0/628 (0%) 0/626 (0%)
    Infection Gr0-2 neut, appendix 0/625 (0%) 0/628 (0%) 1/626 (0.2%)
    Infection Gr0-2 neut, colon 0/625 (0%) 2/628 (0.3%) 0/626 (0%)
    Infection Gr0-2 neut, kidney 1/625 (0.2%) 1/628 (0.2%) 0/626 (0%)
    Infection Gr0-2 neut, lung 2/625 (0.3%) 3/628 (0.5%) 2/626 (0.3%)
    Infection Gr0-2 neut, mediastinm 0/625 (0%) 0/628 (0%) 1/626 (0.2%)
    Infection Gr0-2 neut, mucosa 0/625 (0%) 1/628 (0.2%) 0/626 (0%)
    Infection Gr0-2 neut, muscle 0/625 (0%) 1/628 (0.2%) 0/626 (0%)
    Infection Gr0-2 neut, nerve-cranial 1/625 (0.2%) 0/628 (0%) 0/626 (0%)
    Infection Gr0-2 neut, skin 0/625 (0%) 1/628 (0.2%) 0/626 (0%)
    Infection Gr0-2 neut, urinary tract 1/625 (0.2%) 0/628 (0%) 1/626 (0.2%)
    Infection Gr0-2 neut, vagina 1/625 (0.2%) 0/628 (0%) 0/626 (0%)
    Infection Gr0-2 neut, wound 0/625 (0%) 1/628 (0.2%) 0/626 (0%)
    Infection w/ unk ANC skin (cellulitis) 0/625 (0%) 2/628 (0.3%) 0/626 (0%)
    Infection w/ unk ANC urinary tract NOS 0/625 (0%) 1/628 (0.2%) 0/626 (0%)
    Infection Gr0-2 neut, blood 1/625 (0.2%) 0/628 (0%) 0/626 (0%)
    Infection-other 1/625 (0.2%) 1/628 (0.2%) 0/626 (0%)
    Injury, poisoning and procedural complications
    Wound - non-infectious 0/625 (0%) 1/628 (0.2%) 0/626 (0%)
    Vascular access,Thrombosis/embolism 0/625 (0%) 1/628 (0.2%) 0/626 (0%)
    Investigations
    Leukocytes decreased 3/625 (0.5%) 0/628 (0%) 0/626 (0%)
    Neutrophils decreased 7/625 (1.1%) 2/628 (0.3%) 0/626 (0%)
    Platelets decreased 13/625 (2.1%) 2/628 (0.3%) 1/626 (0.2%)
    Weight gain 0/625 (0%) 0/628 (0%) 2/626 (0.3%)
    Alanine aminotransferase increased 4/625 (0.6%) 4/628 (0.6%) 0/626 (0%)
    Serum amylase increased 0/625 (0%) 1/628 (0.2%) 0/626 (0%)
    Aspartate aminotransferase increased 6/625 (1%) 4/628 (0.6%) 0/626 (0%)
    Blood bilirubin increased 1/625 (0.2%) 1/628 (0.2%) 1/626 (0.2%)
    Hypercholesterolemia 1/625 (0.2%) 0/628 (0%) 0/626 (0%)
    CPK increased 1/625 (0.2%) 1/628 (0.2%) 0/626 (0%)
    Creatinine increased 1/625 (0.2%) 3/628 (0.5%) 0/626 (0%)
    Lipase increased 4/625 (0.6%) 3/628 (0.5%) 1/626 (0.2%)
    Metabolism and nutrition disorders
    Anorexia 11/625 (1.8%) 5/628 (0.8%) 0/626 (0%)
    Dehydration 10/625 (1.6%) 3/628 (0.5%) 0/626 (0%)
    Hypoalbuminemia 1/625 (0.2%) 0/628 (0%) 0/626 (0%)
    Hypocalcemia 1/625 (0.2%) 1/628 (0.2%) 0/626 (0%)
    Hyperglycemia 0/625 (0%) 1/628 (0.2%) 1/626 (0.2%)
    Hypophosphatemia 1/625 (0.2%) 1/628 (0.2%) 0/626 (0%)
    Hyperkalemia 3/625 (0.5%) 1/628 (0.2%) 0/626 (0%)
    Hypokalemia 2/625 (0.3%) 1/628 (0.2%) 0/626 (0%)
    Hypernatremia 1/625 (0.2%) 0/628 (0%) 0/626 (0%)
    Hyponatremia 1/625 (0.2%) 5/628 (0.8%) 4/626 (0.6%)
    Hypertriglyceridemia 2/625 (0.3%) 0/628 (0%) 0/626 (0%)
    Hyperuricemia 0/625 (0%) 1/628 (0.2%) 3/626 (0.5%)
    Musculoskeletal and connective tissue disorders
    Nonneuropathic upper extr muscle weak 1/625 (0.2%) 0/628 (0%) 0/626 (0%)
    Nonneuropathic left-side muscle weak 0/625 (0%) 1/628 (0.2%) 0/626 (0%)
    Nonneuropathic right-side muscle weak 0/625 (0%) 0/628 (0%) 1/626 (0.2%)
    Nonneuropathic generalized weakness 1/625 (0.2%) 1/628 (0.2%) 1/626 (0.2%)
    Myositis 1/625 (0.2%) 0/628 (0%) 0/626 (0%)
    Musculoskeletal/soft tissue-other 0/625 (0%) 2/628 (0.3%) 0/626 (0%)
    Back, pain 1/625 (0.2%) 3/628 (0.5%) 0/626 (0%)
    Bone, pain 2/625 (0.3%) 1/628 (0.2%) 0/626 (0%)
    Extremity-limb, pain 4/625 (0.6%) 3/628 (0.5%) 0/626 (0%)
    Joint, pain 8/625 (1.3%) 8/628 (1.3%) 3/626 (0.5%)
    Muscle, pain 2/625 (0.3%) 8/628 (1.3%) 1/626 (0.2%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Secondary malignancy 0/625 (0%) 1/628 (0.2%) 1/626 (0.2%)
    Nervous system disorders
    Vasovagal episode 1/625 (0.2%) 0/628 (0%) 0/626 (0%)
    Ataxia 0/625 (0%) 0/628 (0%) 1/626 (0.2%)
    CNS cerebrovascular ischemia 4/625 (0.6%) 0/628 (0%) 1/626 (0.2%)
    Cognitive disturbance 0/625 (0%) 1/628 (0.2%) 0/626 (0%)
    Dizziness 4/625 (0.6%) 2/628 (0.3%) 2/626 (0.3%)
    Memory impairment 1/625 (0.2%) 0/628 (0%) 1/626 (0.2%)
    Neuropathy-motor 3/625 (0.5%) 1/628 (0.2%) 0/626 (0%)
    Neuropathy-sensory 3/625 (0.5%) 12/628 (1.9%) 3/626 (0.5%)
    Syncope 4/625 (0.6%) 2/628 (0.3%) 0/626 (0%)
    Head/headache 6/625 (1%) 4/628 (0.6%) 0/626 (0%)
    Psychiatric disorders
    Insomnia 0/625 (0%) 4/628 (0.6%) 0/626 (0%)
    Confusion 2/625 (0.3%) 0/628 (0%) 1/626 (0.2%)
    Anxiety 0/625 (0%) 1/628 (0.2%) 0/626 (0%)
    Depression 1/625 (0.2%) 2/628 (0.3%) 2/626 (0.3%)
    Renal and urinary disorders
    Kidney, hemorrhage 1/625 (0.2%) 0/628 (0%) 0/626 (0%)
    Proteinuria 2/625 (0.3%) 2/628 (0.3%) 0/626 (0%)
    Renal failure 6/625 (1%) 4/628 (0.6%) 0/626 (0%)
    Renal/GU-other 0/625 (0%) 1/628 (0.2%) 0/626 (0%)
    Reproductive system and breast disorders
    Sexual/Reproductive function-Other 0/625 (0%) 1/628 (0.2%) 0/626 (0%)
    Respiratory, thoracic and mediastinal disorders
    Pulmonary hypertension 0/625 (0%) 0/628 (0%) 1/626 (0.2%)
    Muco/stomatitis (symptom) pharynx 24/625 (3.8%) 14/628 (2.2%) 0/626 (0%)
    Nose, hemorrhage 3/625 (0.5%) 0/628 (0%) 0/626 (0%)
    Dyspnea 4/625 (0.6%) 4/628 (0.6%) 2/626 (0.3%)
    Pleural effusion (non-malignant) 1/625 (0.2%) 1/628 (0.2%) 0/626 (0%)
    Voice changes/dysarthria 0/625 (0%) 1/628 (0.2%) 0/626 (0%)
    Skin and subcutaneous tissue disorders
    Dry skin 0/625 (0%) 1/628 (0.2%) 0/626 (0%)
    Nail changes 1/625 (0.2%) 0/628 (0%) 0/626 (0%)
    Pruritus/itching 1/625 (0.2%) 11/628 (1.8%) 1/626 (0.2%)
    Rash/desquamation 15/625 (2.4%) 93/628 (14.8%) 3/626 (0.5%)
    Rash: acne/acneiform 0/625 (0%) 2/628 (0.3%) 0/626 (0%)
    Erythema multiforme 0/625 (0%) 1/628 (0.2%) 0/626 (0%)
    Hand-foot reaction 94/625 (15%) 208/628 (33.1%) 7/626 (1.1%)
    Urticaria 0/625 (0%) 1/628 (0.2%) 0/626 (0%)
    Scalp, pain 0/625 (0%) 2/628 (0.3%) 0/626 (0%)
    Skin, pain 0/625 (0%) 1/628 (0.2%) 0/626 (0%)
    Vascular disorders
    Hypertension 104/625 (16.6%) 96/628 (15.3%) 15/626 (2.4%)
    Hypotension 1/625 (0.2%) 0/628 (0%) 0/626 (0%)
    Thrombosis/thrombus/embolism 3/625 (0.5%) 5/628 (0.8%) 1/626 (0.2%)
    Vascular-Other (Specify) 0/625 (0%) 1/628 (0.2%) 0/626 (0%)
    Other (Not Including Serious) Adverse Events
    Arm A (Sunitinib + Sorafenib Placebo) Arm B (Sorafenib + Sunitinib Placebo) Arm C (Sunitinib Placebo + Sorafenib Placebo)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 116/625 (18.6%) 117/628 (18.6%) 57/626 (9.1%)
    Gastrointestinal disorders
    Diarrhea w/o prior colostomy 41/625 (6.6%) 40/628 (6.4%) 13/626 (2.1%)
    Nausea 33/625 (5.3%) 21/628 (3.3%) 11/626 (1.8%)
    General disorders
    Fatigue 62/625 (9.9%) 58/628 (9.2%) 31/626 (5%)
    Skin and subcutaneous tissue disorders
    Rash/desquamation 17/625 (2.7%) 43/628 (6.8%) 15/626 (2.4%)
    Hand-foot reaction 36/625 (5.8%) 52/628 (8.3%) 7/626 (1.1%)
    Vascular disorders
    Hypertension 38/625 (6.1%) 38/628 (6.1%) 10/626 (1.6%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Study Statistician
    Organization ECOG-ACRIN Statistical Office
    Phone 617-632-3012
    Email
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT00326898
    Other Study ID Numbers:
    • NCI-2009-00534
    • NCI-2009-00534
    • CAN-NCIC-E2805
    • SWOG-E2805
    • ECOG-E2805
    • CDR0000478976
    • CALGB-E2805
    • E2805
    • E2805
    • U10CA180820
    • U10CA021115
    First Posted:
    May 17, 2006
    Last Update Posted:
    Feb 8, 2022
    Last Verified:
    Jan 1, 2022